FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar
DI: 10649111160370
·
Model: 98-495
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sklar
- Primary DI
- 10649111160370
- Version / Model
- 98-495
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-09
- Public Version
- 1
- Public Version Date
- 2019-08-19
- Public Version Status
- New
- Public Device Record Key
- 5a0972e7-af78-4dbb-9e6e-ae50d4f3e824
Device Description
CUTICLE NAIL SCI 3 1/2 FNG NAI
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LRW | SCISSORS, GENERAL, SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38812 | Nail scissors, reusable | A hand-held device designed specifically for cutting the nails of a patient. It is comprised of two pivoted blades with finger and thumb ring-handles, which cut the nails with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed); the blades may be curved to follow the natural curvature of human nails. It is not a pair of nail clippers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10649111160370 | GS1 |