Axiom®

Integral Surg KT Ø3.6-4.2 Empt

Registry build 21.09.26
5manufacturers in China registered for this device type
16catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Shandong (1), Guangdong (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 KCT
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Lianyungang Anson Non-woven Product Co., Ltd. Lianyungang Jiangsu Contract manufacturer 13
Medipack Medical Packaging MFG. Co. Dongguan Guangdong Contract manufacturer 5
AR Medicom Inc., (Asia), Ltd. Hongkong Hong Kong Exporter 5
Wipak Packaging (Changshu) Co., Ltd. Changshu Jiangsu Manufacturer 2

Record

Regulatory record for Axiom®
Listed by Etablissements Anthogyr
FDA product code KCT
Device type Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class Class 2
Regulation 21 CFR 880.6850
Record published 2023-12-10

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, manufacturing date
Sizes Outer diameter 3.6 to 5 mm

Catalogue Numbers

Catalogue numbers for Axiom®
Catalogue number Size Status
INMODOPP3 In distribution
INMODOPS3 In distribution
MODGS42 Outer Diameter 4.2 mm In distribution
INMODOPS3V In distribution
INMODOPP3V In distribution
MODGS36 Outer Diameter 3.6 mm In distribution
MODGS3642V Ø3.6-Ø4.2 mm In distribution
MODGS50 Outer Diameter 5 mm In distribution
MODGS3642 Ø3.6-Ø4.2 mm In distribution
INMODIGM In distribution
INMODOPS3L In distribution
INMODIGMV In distribution
MODGS42V Outer Diameter 4.2 mm In distribution
INMODOPS3LV In distribution
MODGS36V Outer Diameter 3.6 mm In distribution
MODGS50V Outer Diameter 5 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Instrusafe Summit Medical LLC 6,357
V. Mueller Steris Corporation 1,080
Ermis Ermis MedTech 597
Bahadir USA Bahadir USA LLC 561
Avalign Avalign Technologies, Inc. 447
Sklar® Sklar Corporation 363
HNM Medical HNM Stainless, LLC. 337
Surgical Instrument SIN Sistema DE Implante Nacional S.A 295
ReLine Nuvasive, Inc. 290
Case Medical Case Medical, Inc. 289
Millennium Avalign Technologies, Inc. 268
V. Mueller Carefusion 2200, Inc. 174

Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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