FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00817470007534
·
Model: 11-2002
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00817470007534
- Version / Model
- 11-2002
- Catalog Number
- 11-2002
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-30
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 8749ca48-1c8d-4757-9c14-0124dd68279d
Device Description
JAWS RETRO JUNIOR
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42597 | Tendon forceps | A hand-held manual surgical instrument designed for interlacing, seizing, passing, holding, or approximating a tendon during surgery. It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes and shapes and the working end will typically have grasping blades that are shaped in a variety of designs, e.g., fenestrated, flat, curved; those with flat blades are serrated or may have interlocking pins or V-notch at the tip to provide extra grip on the tendon. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817470007534 | GS1 |
Customer Contacts
- Phone
- +1(800)821-5700
- [email protected]