Pomee

Mallet#49 7 1/2" 2oz Lead filled head steel faced

Registry build 21.09.26
6manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXL
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
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
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53

Record

Regulatory record for Pomee
Listed by Pomee Corporation, Pakistan
FDA product code HXL
Device type Mallet
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2021-12-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization, Moist Heat or Steam Sterilization
Supplied sterile Yes

Catalogue Numbers

Catalogue numbers for Pomee
Catalogue number Size Status
702-365 In distribution
702-360 In distribution
702-350 In distribution
702-352 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MSI Precision Specialty Instruments MED Saver, Inc. 115
Surgical Direct Surgical Direct, Inc. 77
Aesculap Aesculap AG 24
Integra® Jarit® Integra LifeSciences Production Corporation 20
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 18
Integra® Miltex® Integra LifeSciences Production Corporation 17
Tecomet Tecomet, Inc. 15
Princeton Princeton Medical Group, Inc. 14
Hayden Medical Hayden Medical Inc 12
General Instruments Alphatec Spine, Inc. 11
Sontec Mallet Sontec Instruments, Inc. 9
Mallet Zimmer, Inc. 8

Showing 12 of 132. All products under Mallet

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