Identity
- Trade Name
- Cutting Block FDA UDI
- Generic Name
- Surgical cutting/shaping board, single-use FDA UDI
- Device Name
- The Cutting Block is intended to provide a sterile cutting surface during surgery. The Cutting Block may be used for cutting MACI(R) (autologous cultured chondrocytes on porcine collagen membrane) implant during implantation surgery. The Cutting Block may be supplied individually in a sealed pouch, or it may be supplied unwrapped as part of the MACI Surgical Implantation Kit. FDA UDI
- Model / Reference
- 89054 FDA UDI
- Description
- The Cutting Block is intended to provide a sterile cutting surface during surgery. The Cutting Block may be used for cutting MACI(R) (autologous cultured chondrocytes on porcine collagen membrane) implant during implantation surgery. The Cutting Block may be supplied individually in a sealed pouch, or it may be supplied unwrapped as part of the MACI Surgical Implantation Kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850037506101 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Surgical cutting/shaping board, single-use 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical cutting/shaping board, single-use
Cutting Block by Vericel Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical cutting/shaping board, single-use.
- MACI Arthroscopic Instruments — Vericel Corporation · 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
- Vericel Corporation
Sources (1)
- FDA UDI 16174c91-efe7-4d0a-ad68-fc569077aab0 33 fields · synced May 30, 2026