FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar®
DI: 10649111291135
·
Model: 48-228
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sklar®
- Primary DI
- 10649111291135
- Version / Model
- 48-228
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-03
- Public Version
- 1
- Public Version Date
- 2019-01-03
- Public Version Status
- New
- Public Device Record Key
- 1c587099-c570-49b2-b7ba-d9ed6b036a44
Device Description
HOLLENBACK CARVER #3 D/E
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 |
|---|---|---|---|---|
| EKH | CARVER, DENTAL AMALGAM, OPERATIVE | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35794 | Dental wax carver | A hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10649111291135 | GS1 |