Avalign

Krause Ear Snare

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code JZD
Manufacturer City Province Registered as Device types
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Avalign
Listed by Avalign Technologies, Inc., United States
FDA product code JZD
Device type Snare, Ear
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-06-23
Record revised 2023-07-06 (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

Catalogue Numbers

Catalogue numbers for Avalign
Catalogue number Size Status
VM101-5761 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 8
V. Mueller Carefusion 2200, Inc. 4
Bausch + Lomb Bausch & Lomb Incorporated 4
Ambler Surgical Ambler Surgical, LLC 3
Aesculap Aesculap AG 2
Bear Mytamed, Inc. 2
V. Mueller Steris Corporation 2
Boss Instruments Boss Instruments, Ltd. 2
mytaMed Mytamed, Inc. 2
Snare KLS-Martin L.P. 2
Novo Surgical Inc. Novo Surgical, Inc. 1
HNM Medical HNM Stainless, LLC. 1

Showing 12 of 13. All products under Snare, Ear

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