FDA UDI
In Commercial Distribution
🇺🇸 United States
Tissue Bank Dermatome
DI: 00889024376014
·
Model: 00-8831-000-10
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tissue Bank Dermatome
- Primary DI
- 00889024376014
- Version / Model
- 00-8831-000-10
- Catalog Number
- 00-8831-000-10
- Company Name
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 137354267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-19
- Public Version
- 1
- Public Version Date
- 2021-10-27
- Public Version Status
- New
- Public Device Record Key
- ecbfff34-6d70-47ea-9079-09d0e590dad8
Device Description
Dermatome Blades
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFD | Dermatome | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35134 | Dermatome blade, single-use | A surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00889024380325 | GS1 | Shelf Carton | 10 | In Commercial Distribution | |
| Primary | 00889024376014 | GS1 | ||||
| Package | 00889024382299 | GS1 | Ship Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]