FDA UDI
In Commercial Distribution
🇺🇸 United States
GENERIC Surgical Instruments
DI: 00841732123786
·
Model: 100.7054
·
CTL Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GENERIC Surgical Instruments
- Primary DI
- 00841732123786
- Version / Model
- 100.7054
- Company Name
- CTL Medical Corporation
- Labeler DUNS
- 080138504
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-02
- Public Version
- 2
- Public Version Date
- 2026-04-15
- Public Version Status
- Update
- Public Device Record Key
- 2556e594-d859-4efb-b26d-88a6954135d0
Device Description
K-Wire, Threaded Trocar Tip, L560mm, D1.4, Nitinol
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63819 | Spinal guidewire | A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841732123786 | GS1 |
Customer Contacts
- Phone
- 1 (214) 545-5820
- [email protected]