FDA UDI
In Commercial Distribution
🇺🇸 United States
Cutting Block
DI: 00850037506101
·
Model: 89054
·
VERICEL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cutting Block
- Primary DI
- 00850037506101
- Version / Model
- 89054
- Company Name
- VERICEL CORPORATION
- Labeler DUNS
- 079745570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-09
- Public Version
- 1
- Public Version Date
- 2022-11-17
- Public Version Status
- New
- Public Device Record Key
- 16174c91-efe7-4d0a-ad68-fc569077aab0
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66494 | Surgical cutting/shaping board, single-use | A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850037506101 | GS1 |