FDA UDI
In Commercial Distribution
🇺🇸 United States
Kirschner wire
DI: 03760225718889
·
Model: K20 NS100
·
In2Bones USA, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Kirschner wire
- Primary DI
- 03760225718889
- Version / Model
- K20 NS100
- Catalog Number
- K20 NS100
- Company Name
- In2Bones USA, LLC
- Labeler DUNS
- 079700711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 6
- Public Version Date
- 2026-04-21
- Public Version Status
- Update
- Public Device Record Key
- 0ce6c5b9-0a3c-4e13-83f4-1ef5004519c7
Device Description
KIRSCHNER WIRE NS DIAM 1.0 MM LENGTH 100 MM 2 SHARP TIPS
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
| JDW | PIN, FIXATION, THREADED | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36249 | Orthopaedic bur, reusable | A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760225718889 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153204 | 000 |