FDA UDI
In Commercial Distribution
🇺🇸 United States
Peri-Loc
DI: 03596010179685
·
Model: 71161012
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Peri-Loc
- Primary DI
- 03596010179685
- Version / Model
- 71161012
- Catalog Number
- 71161012
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-29
- Public Version
- 5
- Public Version Date
- 2024-06-05
- Public Version Status
- Update
- Public Device Record Key
- e34d7df5-f575-4d0d-b395-fc43dd6f1577
Device Description
PERI-LOC K-WIRE 1.25MM X 150MM LENGTH TROCAR POINT
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66935 | Orthopaedic intraoperative positioning pin, single-use | A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23596010179689 | GS1 | BX | 6 | In Commercial Distribution | |
| Primary | 03596010179685 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]