Integra®

Integra® Hough Drum Scraper, 5-7/8", 1mm Point Angle 45° Tip, 2.5mm Angled 60° from Shaft

Registry build 21.09.26
11manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRC
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Elite Medtek(Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Jiangsu Yongle Medical Technology Co., Ltd. Taixing Jiangsu Manufacturer 4

Record

Regulatory record for Integra®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code LRC
Device type Instrument, Ent Manual Surgical
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 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
Sizes Length 1 to 2.5 mm; angle 45 to 60 °
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Integra®
Catalogue number Size Status
3714247 In distribution
7060111 In distribution
3724065 6-1/4″ In distribution
3714035 In distribution
3714249 In distribution
1650025 In distribution
3714034 In distribution
7060114 In distribution
3722109 In distribution
1650030 In distribution
3750012 In distribution
3722032 Length 1 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Instrument, Ent Manual Surgical Karl Storz GmbH & Co. KG 2,062
Fentex Fentex medical GmbH 1,738
Elmed Elmed, Inc. 504
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 441
Evonos Gyrus Acmi, Inc. 291
Millennium Avalign Technologies, Inc. 283
Elmed Incorporated Elmed, Inc. 277
Instrument, Ent Manual Surgical Stryker Leibinger Gmbh & Co. KG 169
Rhinoforce Karl Storz GmbH & Co. KG 112
Surtex Surtex Instruments Ltd 85
Kerrison sphenoid punch Spiggle & Theis Medizintechnik Gmbh 82
Gyrus Acmi Gyrus Acmi, Inc. 78

Showing 12 of 661. All products under Instrument, Ent Manual Surgical

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