FDA UDI
In Commercial Distribution
🇺🇸 United States
Terminal Device
DI: 05055348259325
·
Model: Table Spoon Adult
·
HUGH STEEPER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Terminal Device
- Primary DI
- 05055348259325
- Version / Model
- Table Spoon Adult
- Catalog Number
- B05356
- Company Name
- HUGH STEEPER LIMITED
- Labeler DUNS
- 210280350
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-10
- Public Version
- 1
- Public Version Date
- 2023-07-18
- Public Version Status
- New
- Public Device Record Key
- 6432e18a-bb3a-489b-a3d9-42a827eea724
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 |
|---|---|---|---|---|
| 41084 | Split-hook/specialized-tool hand prosthesis | An artificial substitute for a missing hand that comes in various forms (e.g., a hook or type of tool) and that replaces some of the functions of the hand. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055348259325 | GS1 |