Durogrip

DUROGRIP Wire Twister, straight, 6 1/8", (155 mm), with 0.5 mm pitch of serration, with ratchet, non-sterile, reusable

Registry build 21.09.26
3manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HXS
Manufacturer City Province Registered as Device types
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82

Record

Regulatory record for Durogrip
Listed by Aesculap AG, Germany
FDA product code HXS
Device type Twister, Wire
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-07-07
Record revised 2021-01-13 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Durogrip
Catalogue number Size Status
BM110R In distribution
BM111R In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
gSource Gsource, LLC. 22
Forceps KLS-Martin L.P. 13
Twister, Wire Biomet Microfixation 12
Orthomed Ortho-MED, Inc. 12
NewPort Seaspine Orthopedics Corporation 12
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 11
Integra® Jarit® Integra LifeSciences Production Corporation 10
Ambler Surgical Ambler Surgical, LLC 10
Sklar® Sklar Corporation 9
Millennium Avalign Technologies, Inc. 8
Novo Surgical Inc. Novo Surgical, Inc. 7
Kmedic Teleflex Medical LLC 7

Showing 12 of 57. All products under Twister, Wire

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer