FDA UDI
In Commercial Distribution
🇺🇸 United States
COSMETIC HAND
DI: 05055348280237
·
Model: Cosmetic Hand Right Male Adult - Long Fingers
·
HUGH STEEPER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COSMETIC HAND
- Primary DI
- 05055348280237
- Version / Model
- Cosmetic Hand Right Male Adult - Long Fingers
- Catalog Number
- FHL22
- Company Name
- HUGH STEEPER LIMITED
- Labeler DUNS
- 210280350
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- 880e7922-d142-4ed7-98cb-5b9695c597b8
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRA | Hand, External Limb Component, Mechanical | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41078 | Passive hand prosthesis | An artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to move only as a result of the direct application of external forces. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055348280237 | GS1 |