FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar®
DI: 10649111177200
·
Model: 16-2820
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sklar®
- Primary DI
- 10649111177200
- Version / Model
- 16-2820
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-09
- Public Version
- 1
- Public Version Date
- 2018-04-09
- Public Version Status
- New
- Public Device Record Key
- cd7bd791-6a64-4f0a-9988-db20ea281879
Device Description
BRUNS PLASTER SHEAR 9 1/2" TC
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 |
|---|---|---|---|---|
| 46314 | Cast cutting scissors | A hand-held surgical instrument with specially strong, curved blades that is used to cut small plaster cast dressings and layers of thick material, e.g., bandages. It is designed like a strong pair of scissors with two pivoted blades usually provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded or have a pod at the tip for safety. The longest blade is inserted between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create the cutting effect. It is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10649111177200 | GS1 |