FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Ti6® Internal Fixation System
DI: 10381780245896
·
Model: KW1102P
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ti6® Internal Fixation System
- Primary DI
- 10381780245896
- Version / Model
- KW1102P
- Catalog Number
- KW1102P
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-05
- Public Version
- 5
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 506c617e-fab9-4db1-96af-e0478ebe9b1f
- Distribution End Date
- 2023-03-31
Device Description
Integra® Ti6® The threaded guide wire is used as a guide for placement or insertion of a device. It is used with the Ti6 TC-Series.
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
- 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 |
|---|---|---|---|---|
| HXI | PASSER, WIRE, ORTHOPEDIC | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46165 | Orthopaedic guidewire, reusable | A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M269KW1102P1 | HIBCC | ||||
| Primary | 10381780245896 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3.94in L x .035in diameter |