FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar
DI: 40649111117153
·
Model: 21-787
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Sklar
- Primary DI
- 40649111117153
- Version / Model
- 21-787
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2019-03-19
- Public Version
- 1
- Public Version Date
- 2019-03-27
- Public Version Status
- New
- Public Device Record Key
- d3d29ce7-73f2-44f0-a515-d4bf1f287fc7
Device Description
FEILCHENFELD SPLINTR FCP 4 1/2
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44445 | Cast/plaster saw | A hand-held manual device designed to cut through or trim the plaster of a cast. It is typically a one-piece device consisting of a handle attached to a short, curved, toothed blade 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 | 40649111117153 | GS1 | ||||
| Unit of Use | 00649111117155 | GS1 |