FDA UDI
In Commercial Distribution
🇺🇸 United States
comknife®
DI: 06971503604511
·
Model: B10*450/P18.8*49
·
Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- comknife®
- Primary DI
- 06971503604511
- Version / Model
- B10*450/P18.8*49
- Company Name
- Beijing Bohai Kangyuan Medical Devices Co., Ltd.
- Labeler DUNS
- 552747785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-28
- Public Version
- 1
- Public Version Date
- 2025-09-05
- Public Version Status
- New
- Public Device Record Key
- 9225b9fd-4992-45d3-8134-b41b642893bc
Device Description
Is used with external fixator of operating tables, the foam pad is used to separate patient’s foot, ankle, and leg from the foot bracket of external fixators of operating table, the elastic bandage used to fix firmly the patient’s position and foot bracket of external fixators of operating table.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34864 | Adhesive bandage | A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971503602040 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 06971503604511 | GS1 |