Aesculap

Lewis Tonsil Snare 260MM & #8 Snre Wires

Registry build 21.09.26
2manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KBZ
Manufacturer City Province Registered as Device types
Hangzhou Ruihao Medical Technology Ltd Hangzhou Zhejiang Contract manufacturer 12
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Record

Regulatory record for Aesculap
Listed by Aesculap AG, Germany
FDA product code KBZ
Device type Snare, Tonsil
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-04-24
Record revised 2022-08-15 (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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Per pack Status
MA493R In distribution
OM776R In distribution
OM768R In distribution
OM758R 100 In distribution
OM757R 100 In distribution
OM751R 12 In distribution
OM781R In distribution
OM760R In distribution
OM750R 12 In distribution
MA490R 12 In distribution
MA714R In distribution
OM761R In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 21
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 11
Pilling Teleflex Medical LLC 11
Integra® Jarit® Integra LifeSciences Production Corporation 10
Bausch + Lomb Bausch & Lomb Incorporated 9
Integra® Miltex® Integra LifeSciences Production Corporation 8
MSI Precision Specialty Instruments MED Saver, Inc. 7
Integra® Integra LifeSciences Production Corporation 7
Snare KLS-Martin L.P. 7
Novo Surgical Novo Surgical, Inc. 7
Boss Instruments Boss Instruments, Ltd. 6
Richard-Allan® Tonsil Snare Aspen Surgical Products, Inc. 6

Showing 12 of 28. All products under Snare, Tonsil

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