FDA UDI
In Commercial Distribution
🇺🇸 United States
Chiroklip wire protector 2 pack blister/box with 25 blisters
DI: 05060079820355
·
Model: CKB2
·
OSTEOTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Chiroklip wire protector 2 pack blister/box with 25 blisters
- Primary DI
- 05060079820355
- Version / Model
- CKB2
- Catalog Number
- CKB2
- Company Name
- OSTEOTEC LIMITED
- Labeler DUNS
- 348489386
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-02-04
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 3116cac3-eccb-452a-bbda-ce2007ddd010
Device Description
ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is designed to fold around the end of a K wire and to safely protect the wearer from the risk of injury or re-injury through catching the sharp end of the K wire on clothing, bedclothes, people or other objects. Each Chiroklip box contain 25 Chiroklip pairs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXQ | Crimper, Pin | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65406 | Orthopaedic bone pin cover | A small device intended to enclose/cover the protruding end of an orthopaedic bone pin [e.g., Kirschner wire (K-Wire)] to prevent snagging objects in the environment and injury or discomfort to the patient while the wire is in situ. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060079820355 | GS1 | ||||
| Unit of Use | 05060079820003 | GS1 |