FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrapac
DI: 05010058088610
·
Model: 8861
·
ROBINSON HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Instrapac
- Primary DI
- 05010058088610
- Version / Model
- 8861
- Catalog Number
- 8861
- Company Name
- ROBINSON HEALTHCARE LIMITED
- Labeler DUNS
- 237799775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-08
- Public Version
- 1
- Public Version Date
- 2023-08-16
- Public Version Status
- New
- Public Device Record Key
- ba5f194f-b0b8-4886-a29a-244e00bce4f1
Device Description
Instrapac Podiatry Nail Cutter - Soft Grip Curved R/S X 20
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FZT | Cutter, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64032 | Nail clippers, single-use | A sterile, hand-held device designed specifically for trimming the nails of a patient. Also known as a nail cutter, it is a robust instrument comprised of two hinged cutting blades that are conjoined at the handle end of the device. The blades are sprung to hold them apart when not activated; when activated, the two blades are pressed together in a chopping motion to bite off (clip) the nail that has been positioned between them. It is not a pair of nail scissors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05010058188617 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 05010058088610 | GS1 |
Customer Contacts
- Phone
- +441909735502
- [email protected]