Rebstock Instruments
⚠️ Moderate Risk
FEI: 3009058024 • Duerbheim • GERMANY
FEI Number
3009058024
Location
Duerbheim
Country
GERMANYAddress
In Welheraecker 77, , Duerbheim, , Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2011 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79FZQCLIP, REMOVABLE (SKIN) | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 84HCHCLIP, ANEURYSM | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79HBTAPPLIER, HEMOSTATIC CLIP | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79HTFCURETTE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 78FHQHOLDER, NEEDLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 87HTXRONGEUR | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79FXESPECULUM, NON-ILLUMINATED | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79HXDCLAMP | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/30/2011 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Rebstock Instruments's FDA import refusal history?
Rebstock Instruments (FEI: 3009058024) has 14 FDA import refusal record(s) in our database, spanning from 8/30/2011 to 8/30/2011.
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. Rebstock Instruments's FEI number is 3009058024.
What types of violations has Rebstock Instruments received?
Rebstock Instruments has been cited for 1 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 Rebstock Instruments come from?
All FDA import refusal data for Rebstock Instruments 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.