Identity
- Trade Name
- Skin Flap Gauge 7 FDA UDI
- Generic Name
- Skin flap thickness gauge FDA UDI
- Device Name
- Reusable Surgical Tool FDA UDI
- Model / Reference
- 50156 FDA UDI
- Description
- Reusable Surgical Tool FDA UDI
Identifiers
- Catalog Number
- 10763-003 FDA UDI
- Primary DI / UDI-DI
- 09008738501562 FDA UDI
- PMA Number
- P990052 FDA UDI
- FDA Product Code
- MPV FDA UDI
- GMDN Term
- Skin flap thickness gauge FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
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
Category: Skin flap thickness gauge
Skin Flap Gauge 7 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin flap thickness gauge.
Cleared under the same submission
P990052 also covers:
- AP Adapter — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Remote Control — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi AP unit, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi AP unit, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi PoM, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi PoM, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi User Kit, Left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi User Kit, Right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo AP unit, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo AP unit, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo PoM, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo PoM, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 047f9c69-5b17-4cf5-88cd-8d9f6d0da59e 36 fields · synced Jun 8, 2026