FDA UDI
In Commercial Distribution
🇺🇸 United States
Smooth Pin - 3.2mm x 110mm
DI: 09421038411377
·
Model: 5000-2502
·
ENZTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Smooth Pin - 3.2mm x 110mm
- Primary DI
- 09421038411377
- Version / Model
- 5000-2502
- Catalog Number
- 5000-2502
- Company Name
- ENZTEC LIMITED
- Labeler DUNS
- 592616445
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- bc97df61-bdaf-4e23-9431-39f2bfac1c82
Device Description
A single use surgical instrument intended to be used during an orthopaedic surgical procedure
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
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 09421038411360 | GS1 | ||||
| Primary | 09421038411377 | GS1 |