FDA UDI
In Commercial Distribution
🇺🇸 United States
CoLink
DI: 00810021869827
·
Model: P02 N0231
·
In2Bones USA, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CoLink
- Primary DI
- 00810021869827
- Version / Model
- P02 N0231
- Catalog Number
- P02 N0231
- Company Name
- In2Bones USA, LLC
- Labeler DUNS
- 079700711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-12
- Public Version
- 2
- Public Version Date
- 2025-08-04
- Public Version Status
- Update
- Public Device Record Key
- 8e578fa4-a231-4f40-975b-d71287a319a9
Device Description
MIS PLATE TARGETING GUIDE, KWIRE GUIDE
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35095 | Surgical drill guide, reusable | A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810021869827 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213069 | 000 |