Kwik Kleen

Kwik Kleen Kerrison 1mm, 180mm, 40 Degree

Registry build 21.09.26
1manufacturer
42catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

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

Record

Regulatory record for Kwik Kleen
Listed by National Advanced Endoscopy Devices, Inc., United States
FDA product code HAE
Device type Rongeur, Manual
Device class Class 2
Regulation 21 CFR 882.4840
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k) K023868
Record published 2018-04-26
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Kwik Kleen
Catalogue number Size Status
8527-15 In distribution
2002-5A In distribution
8527-10 In distribution
2002-3A In distribution
8527-11 In distribution
8527-17 In distribution
8527-02 In distribution
8527-A6 In distribution
1102-3A In distribution
2002-2A In distribution
1102-5A In distribution
1102-2AC In distribution
1102-1A In distribution
1102-2A-270 In distribution
8527-00 In distribution
8527-19 In distribution
8527-C6 In distribution
2002-4A In distribution
1102-1AC In distribution
1102-1A-270 In distribution
8527-18 In distribution
1102-4A In distribution
8527-03 In distribution
8527-07 In distribution
8527-16 In distribution
1102-5AC In distribution
8527-09 In distribution
8527-06 In distribution
1102-2A In distribution
8527-00 In distribution
1102-4AC In distribution
1102-3AC In distribution
8527-04 In distribution
8527-14 In distribution
8527-01 In distribution
8527-13 In distribution
2002-1A In distribution
8527-12 In distribution
8527-E6 In distribution
8527-B6 In distribution
8527-08 In distribution
8527-05 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 1,397
GEN2 Surgix Medical LLC 1,350
Boss Instruments Boss Instruments, Ltd. 1,086
Avalign Avalign Technologies, Inc. 881
Ambler Surgical Ambler Surgical, LLC 723
V. Mueller Steris Corporation 685
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 476
Rongeur, Manual Fehling Instruments GmbH 383
DANmed Dannoritzer Medizintechnik GmbH & Co. KG 365
Wiggins Medical Ebner Medical LLC 343
Punch KLS-Martin L.P. 333
Stealth Surgical Boss Instruments, Ltd. 242

Showing 12 of 158. All products under Rongeur, Manual

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