FDA UDI
In Commercial Distribution
🇺🇸 United States
Carbon Surgical Blades Sterile #21
DI: 30818087010499
·
Model: 12202100
·
PROPPER MANUFACTURING COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
150
Basic Information
- Brand Name
- Carbon Surgical Blades Sterile #21
- Primary DI
- 30818087010499
- Version / Model
- 12202100
- Catalog Number
- 12202100
- Company Name
- PROPPER MANUFACTURING COMPANY, INC.
- Labeler DUNS
- 001483130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2020-03-06
- Public Version
- 2
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- f3ea4792-2c20-42d7-ae14-a6b99b1d2399
Device Description
Carbon Surgical Blades Sterile #21
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GES | Blade, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12253 | Skin grafting knife | A hand-held, one-piece, manual surgical instrument designed to cut donor-site skin strips intended for grafting. It has a knife-like design with a flat broad blade and a sharp cutting edge; it is usually made of stainless steel. This device may reflect old technology. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10818087010495 | GS1 | ||||
| Primary | 30818087010499 | GS1 |