FDA UDI In Commercial Distribution 🇺🇸 United States

comknife®

DI: 06971503600216 · Model: JPD-DB-W · Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
comknife®
Primary DI
06971503600216
Version / Model
JPD-DB-W
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
69842fd9-727a-4446-8208-b2de700caf6a

Device Description

Is used with disposable microsurgical scalpels forfine sectioning and stripping of blood vessels and soft tissues in surgery ormicrosurgery.

Device Characteristics

Single Use
No
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
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
GDI Dissector, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
12235 Scalpel handle, reusable

Identifiers

Type ID
Package 16971503601944
Primary 06971503600216