Avalign

Guilford-Wright Duckbill Elevator, curved blade, BW 3.5mm, OL 143mm (5 5/8")

Registry build 21.09.26
3manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1).

Chinese manufacturers registered for FDA product code KAD
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54

Record

Regulatory record for Avalign
Listed by Avalign Technologies, Inc., United States
FDA product code KAD
Device type Elevator, Ent
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2021-11-03
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
VM104-1521 In distribution
VM104-1511 In distribution
VM104-1518 In distribution
VM104-1589 In distribution
VM104-1551 In distribution
VM101-4212 In distribution
VM104-1526 In distribution
VM104-1591 In distribution
VM104-1561 In distribution
VM101-4214 In distribution
VM104-1576 In distribution
VM104-1573 In distribution
VM107-6668 In distribution
VM104-1580 In distribution
VM104-1519 In distribution
VM107-6671 In distribution
VM104-1596 In distribution
VM104-1542 In distribution
VM104-1545 In distribution
VM104-1544 In distribution
VM104-1685 In distribution
VM101-5406 In distribution
VM101-5527 In distribution
VM104-1581 In distribution
VM104-1569 In distribution
VM101-4424 In distribution
VM104-1588 In distribution
VM104-1568 In distribution
VM104-1527 In distribution
VM104-1586 In distribution
VM104-1541 In distribution
VM104-1516 In distribution
VM104-1543 In distribution
VM104-1562 In distribution
VM104-1556 In distribution
VM107-6669 In distribution
VM101-4632 In distribution
VM104-1536 In distribution
VM101-4213 In distribution
VM104-1571 In distribution
VM104-1566 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 105
MicroFrance® Integra Microfrance SAS 75
Boss Instruments Boss Instruments, Ltd. 66
V. Mueller Steris Corporation 60
Novo Surgical Novo Surgical, Inc. 54
Novo Surgical Inc. Novo Surgical, Inc. 49
Integra® Jarit® Integra LifeSciences Production Corporation 49
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 45
Millennium Avalign Technologies, Inc. 43
Pilling Teleflex Medical LLC 43
Integra® Miltex® Integra LifeSciences Production Corporation 35
Elevator KLS-Martin L.P. 35

Showing 12 of 111. All products under Elevator, Ent

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