Identity
- Trade Name
- Graft Slivering Board FDA UDI
- Generic Name
- Surgical cutting/shaping board, reusable FDA UDI
- Device Name
- A dissection board used to dissect follicles from a strip of skin removed from the donor area of the scalp so that the follicles can be processed before it is transplanted into the recipient area. An LED backlight can be attached from underneath to aid in this dissection. FDA UDI
- Model / Reference
- Graft Slivering Board FDA UDI
- Description
- A dissection board used to dissect follicles from a strip of skin removed from the donor area of the scalp so that the follicles can be processed before it is transplanted into the recipient area. An LED backlight can be attached from underneath to aid in this dissection. FDA UDI
Identifiers
- Catalog Number
- 621.000 FDA UDI
- Primary DI / UDI-DI
- 00810072351197 FDA UDI
- FDA Product Code
- KET FDA UDI
- GMDN Term
- Surgical cutting/shaping board, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Graft Slivering Board by Cole Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cole Instruments
Sources (1)
- FDA UDI 7a467c5e-46cf-4403-acd5-a4a42999ad46 35 fields · synced Jun 1, 2026