GEN2

Ostrum Antrum Punch, Adult, Straight 2.5MM X 7MM Bite, 92MM Shaft

Registry build 21.09.26
2manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KAW
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Record

Regulatory record for GEN2
Listed by Surgix Medical LLC, United States
FDA product code KAW
Device type Punch, Antrum
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-08-19

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
Sizes Outer diameter 3.5 mm; angle 45 °

Catalogue Numbers

Catalogue numbers for GEN2
Catalogue number Size Status
G2E2596 Outer Diameter 3.5 mm In distribution
G2E2590 In distribution
G2E2595 Outer Diameter 3.5 mm In distribution
G2E2587 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. 28
Aesculap Aesculap AG 24
Ambler Surgical Ambler Surgical, LLC 20
HNM Medical HNM Stainless, LLC. 18
BR Surgical, LLC BR Surgical LLC 18
Novo Surgical Inc. Novo Surgical, Inc. 17
Integra® Integra LifeSciences Production Corporation 16
Pilling Teleflex Medical LLC 13
Millennium Avalign Technologies, Inc. 13
Symmetry Surgical Aspen Surgical Products, Inc. 12
Bausch + Lomb Bausch & Lomb Incorporated 11
Boss Instruments Boss Instruments, Ltd. 11

Showing 12 of 26. All products under Punch, Antrum

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