FDA UDI
In Commercial Distribution
🇺🇸 United States
SCHARF
DI: 08681506800039
·
Model: Fue Punch non serrated0.7 mm 23.5mm
·
SCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETI
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCHARF
- Primary DI
- 08681506800039
- Version / Model
- Fue Punch non serrated0.7 mm 23.5mm
- Catalog Number
- 51-007-35
- Company Name
- SCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETI
- Labeler DUNS
- 533150623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-08
- Public Version
- 1
- Public Version Date
- 2025-12-16
- Public Version Status
- New
- Public Device Record Key
- 1e0ce26a-c446-4254-8704-64dfec707b1b
Device Description
A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.
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
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRY | Punch, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35290 | Hair extraction punch | A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08681506800039 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.6 | Millimeter |