FDA UDI
In Commercial Distribution
🇺🇸 United States
Kwire tip protector Dia 1.2/1.6 mm sterile
DI: 03760225714782
·
Model: K01 10131
·
IN2BONES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kwire tip protector Dia 1.2/1.6 mm sterile
- Primary DI
- 03760225714782
- Version / Model
- K01 10131
- Catalog Number
- K01 10131
- Company Name
- IN2BONES
- Labeler DUNS
- 263616749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 3
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- b775c347-8a0c-4eb3-a174-ce224300568f
Device Description
Kwire tip protector Dia 1.2/1.6 mm sterile
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
- MR Safe
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760225714782 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]