Identity
- Trade Name
- Sklar FDA UDI
- Generic Name
- Soft-tissue surgical hook, reusable FDA UDI
- Device Name
- EXPLORING HOOK 3.5MM SHARP STR FDA UDI
- Model / Reference
- 45-6237 FDA UDI
- Description
- EXPLORING HOOK 3.5MM SHARP STR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111233289 FDA UDI
- FDA Product Code
- GDG FDA UDI
- GMDN Term
- Soft-tissue surgical hook, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Soft-tissue surgical hook, reusable
Sklar by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Sklar Corporation
Sources (1)
- FDA UDI 10ccdee0-429e-42ba-ab4c-99427ce5e58f 33 fields · synced Jun 8, 2026