FDA UDI
In Commercial Distribution
🇺🇸 United States
Silicone Glove
DI: 05055348297273
·
Model: EP GLOVE 7.75 LEFT MALE E5
·
HUGH STEEPER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silicone Glove
- Primary DI
- 05055348297273
- Version / Model
- EP GLOVE 7.75 LEFT MALE E5
- Catalog Number
- TSG302/E5-EP
- Company Name
- HUGH STEEPER LIMITED
- Labeler DUNS
- 210280350
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-13
- Public Version
- 1
- Public Version Date
- 2023-07-21
- Public Version Status
- New
- Public Device Record Key
- 97e3987f-75ce-49b6-9149-0753563a5fe0
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 |
|---|---|---|---|---|
| IPM | Cover, Limb | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64736 | External limb prosthesis finishing component, non-customized | A prefabricated cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) ready to be assembled, fitted, and adjusted to the patient. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055348297273 | GS1 |