Integra®

Integra® Paparella Duckbill Elevator, 6-1/2", 3.5mm Wide, Slightly Curved Sharp Blade

Registry build 21.09.26
3manufacturers in China registered for this device type
30catalogue 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 Integra®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code KAD
Device type Elevator, Ent
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-09-17
Record revised 2023-04-17 (version 7)

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 Width 2 to 9 mm; length 79 to 171.5 mm; outer diameter 2 to 2.5 mm; length 7 in; angle 15 °

Catalogue Numbers

Catalogue numbers for Integra®
Catalogue number Size Status
3714781 6-1/2″ In distribution
3714039 7-3/4″ In distribution
7060113 Length 171.5 mm In distribution
3714383 8-3/4″ In distribution
3714119 In distribution
3714782 6-1/4″ In distribution
7060112 In distribution
3711099 7-3/4″ In distribution
3714038 Width 5 mm In distribution
3714118 Outer Diameter 2.5 mm In distribution
3724060 7-1/4″ In distribution
3722014 In distribution
3724284 Outer Diameter 2 mm In distribution
3714126 10-1/4″ In distribution
3714117 7-1/2″ In distribution
3722115 Width 3.5 mm In distribution
3722015 In distribution
3714127 8-1/2″ In distribution
3714123 In distribution
3714381 7-3/4″ In distribution
3714660 In distribution
3722016 6-1/2″ In distribution
3714114 In distribution
3714121 8-1/4″ In distribution
3714382 7-3/4″ In distribution
3714040 8″ In distribution
3724283 6-1/2″ In distribution
3722048 6-1/4″ In distribution
3714125 6-3/4″ In distribution
3714372 Width 4.5 mm 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
Avalign Avalign Technologies, Inc. 41
Integra® Miltex® Integra LifeSciences Production Corporation 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