FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSSELL-TAYLOR
DI: 03596010040367
·
Model: 112004
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RUSSELL-TAYLOR
- Primary DI
- 03596010040367
- Version / Model
- 112004
- Catalog Number
- 112004
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-13
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 299c0e31-5b86-4409-a4d9-b8f484036a42
Device Description
TROCAR PIN 4 X 240 DELTA FEMORAL RECON TIBIA RETRO IMSC REV
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDW | PIN, FIXATION, THREADED | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47457 | Orthopaedic trocar blade, reusable | A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010040367 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120871 | 000 |