comknife®

FDA UDI

Class I (US FDA UDI)

by Beijing Bohai Kangyuan Medical Devices Co., Ltd.

Identity

Trade Name: comknife® FDA UDI
Generic Name: Scalpel handle, reusable FDA UDI
Device Name: Is used with disposable microsurgical scalpels forfine sectioning and stripping of blood vessels and soft tissues in surgery ormicrosurgery. FDA UDI
Model / Reference: JPD-DB-W FDA UDI
Description: Is used with disposable microsurgical scalpels forfine sectioning and stripping of blood vessels and soft tissues in surgery ormicrosurgery. FDA UDI

Identifiers

Primary DI / UDI-DI: 06971503600216 FDA UDI
FDA Product Code: GDI FDA UDI
GMDN Term: Scalpel handle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Scalpel handle, reusable

comknife® by Beijing Bohai Kangyuan Medical Devices Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Beijing Bohai Kangyuan Medical Devices Co., Ltd.

Sources (1)

FDA UDI 69842fd9-727a-4446-8208-b2de700caf6a 33 fields · synced May 30, 2026