Identity
- Trade Name
- Sklar FDA UDI
- Generic Name
- Brain spatula FDA UDI
- Device Name
- CAIRNS BRAIN SPAT 19X200MM FDA UDI
- Model / Reference
- 50-4426 FDA UDI
- Description
- CAIRNS BRAIN SPAT 19X200MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111169403 FDA UDI
- FDA Product Code
- GAF FDA UDI
- GMDN Term
- Brain spatula 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: Brain spatula
Sklar by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brain spatula.
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- PILLING — TELEFLEX INCORPORATED · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- LAZIC — Peter Lazic GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- AESCULAP — AESCULAP, INC. · Class I
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 30ca7084-76cb-4566-9477-eb2567a03824 33 fields · synced May 31, 2026