Who else makes this device?

Name: Bauer Guarded Osteo 6MM STR
Brand: Bauer Guarded Osteo 6MM STR

Bauer Guarded Osteo 6MM STR

Catalogue number 20-0014-6, listed by W.H. Holden, Inc., under Chisel, Bone, Surgical. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (3), Shandong (1), Guangxi (1).

Chinese manufacturers registered for FDA product code EML
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Xinhua Surgical Instrument Co., Ltd.	Zibo	Shandong	Manufacturer	222
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Shanghai Kangqiao Dental Instruments Factory	Shanghai	Shanghai	Manufacturer	54
Guilin Yikeshi Medical Device Co Ltd	Guilin	Guangxi	Manufacturer	28

Record

Regulatory record for Bauer Guarded Osteo 6MM STR
Listed by	W.H. Holden, Inc.
FDA product code	EML
Device type	Chisel, Bone, Surgical
Device class	Class 1
Regulation	21 CFR 872.4565
Premarket notification	Exempt
Record published	2023-12-20

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Bauer Guarded Osteo 6MM STR
Catalogue number	Size	Status
20-0014-6		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HU-Friedy	HU-Friedy MFG Co., LLC	71
Quinelato	Schobell Industrial Ltda	55
Stoma®	Storz AM Mark Gmbh	33
devemed	Devemed Gmbh	30
Zoll-Dental	Zoll-Dental	29
Power Dental USA	Power Dental U.S.A. Inc.	24
J & J Instruments	J & J Instruments, LLC	17
Millennium	Avalign Technologies, Inc.	16
Integra® Miltex®	Integra LifeSciences Production Corporation	16
Nordent Manufacturing, Inc.	Nordent Manufacturing Inc	15
Brasseler USA	Peter Brasseler Holdings, LLC	14
Helmut Zepf	Helmut Zepf Medizintechnik Gmbh	14

Showing 12 of 50. All products under Chisel, Bone, Surgical

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.