Integra® Jarit®

Integra® Jarit® Cobb-Type Spinal Gouge, 9-1/4", 7.7mm Wide, Solid Hexagonal Handle, Reverse Curved

Registry build 21.09.26
4manufacturers in China registered for this device type
64catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GDH
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106

Record

Regulatory record for Integra® Jarit®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code GDH
Device type Gouge, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-04-02
Record revised 2024-03-25 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Length 6 to 8 in; width 5 to 22 mm; width 1 in
Distribution end date 2023-12-04

Catalogue Numbers

Catalogue numbers for Integra® Jarit®
Catalogue number Size Status
250185 In distribution
250197 In distribution
251243 In distribution
250196 In distribution
250189 In distribution
400247 In distribution
250183 In distribution
250221 Length 8 in In distribution
250332 Width 18 mm In distribution
P4418 Length 6 in In distribution
X20895 In distribution
P4417 In distribution
250233 In distribution
410313 In distribution
250222 Length 8 in In distribution
840140 In distribution
X20887 In distribution
250230 In distribution
251240 In distribution
250225 Width 1 in In distribution
250242 In distribution
251241 In distribution
250241 In distribution
250240 In distribution
250236 In distribution
250333 Width 22 mm In distribution
250330 Width 10 mm In distribution
250234 In distribution
250198 In distribution
251242 In distribution
250191 In distribution
250188 In distribution
X20883 In distribution
250195 In distribution
250182 In distribution
X20881 In distribution
250194 In distribution
250331 Length 8 in In distribution
250220 Length 8 in In distribution
250181 In distribution
P7665 In distribution
250235 In distribution
250243 In distribution
250184 In distribution
250232 In distribution
P4419 Width 5 mm In distribution
250186 In distribution
250226 Length 8 in In distribution
250199 In distribution
250192 In distribution
250224 3/4 Inch Width In distribution
250180 In distribution
250231 In distribution
250187 In distribution
250190 In distribution
X20885 In distribution
250193 In distribution
P7595 In distribution
250223 Length 8 in In distribution
X38391 In distribution
X31385 Withdrawn
X29487 Withdrawn
X20896 Withdrawn
X29515 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 206
Ambler Surgical Ambler Surgical, LLC 164
Life Instruments Life Instrument Corp. 131
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 103
Surtex Surtex Instruments Ltd 95
Novo Surgical Novo Surgical, Inc. 89
MSI Precision Specialty Instruments MED Saver, Inc. 86
Aesculap Aesculap AG 82
gSource Gsource, LLC. 71
Orthomed Ortho-MED, Inc. 60
Boss Instruments Boss Instruments, Ltd. 53
Gouge KLS-Martin L.P. 40

Showing 12 of 77. All products under Gouge, Surgical, General & Plastic Surgery

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