Protesis Y Material Medico Espec

⚠️ Moderate Risk

FEI: 3009682046 • Puerto Cortes, Cortes • HONDURAS

FEI

FEI Number

3009682046

📍

Location

Puerto Cortes, Cortes

🇭🇳

Country

HONDURAS

🏢

Address

Bo Copan 3 Avenida 12-13 Calle, , Puerto Cortes, Cortes, Honduras

Moderate Risk

FDA Import Risk Assessment

35.4

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

9/14/2012

Latest Refusal

9/14/2012

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

1186×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3416×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5086×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
9/14/2012	74MFBSYSTEM, BALLOON ANGIOPLASTY CATHETER, REPROCESSING	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/14/2012	74OFCCATHETER INTRODUCER KIT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/14/2012	74OFBCATHETER GUIDE WIRE KIT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/14/2012	74MAFSTENT, CARDIOVASCULAR	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/14/2012	74DTLADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/14/2012	74NIQSTENT, CORONARY, DRUG-ELUTING	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Protesis Y Material Medico Espec's FDA import refusal history?

Protesis Y Material Medico Espec (FEI: 3009682046) has 6 FDA import refusal record(s) in our database, spanning from 9/14/2012 to 9/14/2012.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Protesis Y Material Medico Espec's FEI number is 3009682046.

What types of violations has Protesis Y Material Medico Espec received?

Protesis Y Material Medico Espec has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Protesis Y Material Medico Espec come from?

All FDA import refusal data for Protesis Y Material Medico Espec is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.