Identity
- Trade Name
- Depth Stop, FH7 EUDAMEDNA FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Device Name
- Depth Stop EUDAMEDDepth Stop, FH7 FDA UDI
- Model / Reference
- ASY-00903 EUDAMEDFDA UDI
- Description
- Depth Stop, FH7 FDA UDI
Identifiers
- Catalog Number
- ASY-00903 FDA UDI
- Primary DI / UDI-DI
- 00840200405652 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081000472DEPTHSTOPSHZ EUDAMED
- Direct Marketing DI
- 00840200405652 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument/implant depth limiter, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Depth Stop, FH7 by Integrity Implants Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081000472DEPTHSTOPSHZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Integrity Implants Inc.
- EUDAMED SRN
- US-MF-000009805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED fd67789c-bda7-4dc7-b5f9-a8e4909a6026 61 fields · synced Jun 17, 2026
- FDA UDI 47ea5711-7b1a-4ae2-bebf-2c524b60ed2f 35 fields · synced May 24, 2026