Bongold Bone Graft Material

FDA UDI

Class II (US FDA UDI)

by Beijing Allgens Medical Science & Technology Co., Ltd.

Identity

Trade Name: Bongold Bone Graft Material FDA UDI
Generic Name: Bone grafting cannula FDA UDI
Model / Reference: Gr-1 FDA UDI

Identifiers

Catalog Number: Particles FDA UDI
Primary DI / UDI-DI: 06953122702281 FDA UDI
510(k) Number: K141725 FDA UDI
FDA Product Code: MQV FDA UDI
GMDN Term: Bone grafting cannula FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bone grafting cannula

Bongold Bone Graft Material by Beijing Allgens Medical Science & Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone grafting cannula.

Arthrex® — Arthrex, Inc. · Class I
AccuPort® Cannula — Zimmer Knee Creations, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Vital™ — BIOMET SPINE LLC · Class I
AccuPort Cannula End Delivery 8 GA x 150mm Drill Length — Zimmer Knee Creations, Inc. · Class I
One-Shot — Shanghai Kinetic Medical Co., Ltd. · Class I
Vital™ — BIOMET SPINE LLC · Class I
Precision Cannula — Zimmer, Inc. · Class I

Cleared under the same submission

K141725 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Beijing Allgens Medical Science & Technology Co., Ltd.

Sources (1)

FDA UDI 98ed6a83-47be-4927-8606-cbae4e8894a3 34 fields · synced May 31, 2026