StripRight

1000 µm StripRight Fiber Strip and Scribe Tool

Registry build 21.09.26
7manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Shandong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HRT
Manufacturer City Province Registered as Device types
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28

Record

Regulatory record for StripRight
Listed by Optical Integrity, Inc., United States
FDA product code HRT
Device type Stripper, Surgical
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2016-11-03
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 10 to 37 °C; Special storage condition: store at room temperature
Packaging Box of 5

Catalogue Numbers

Catalogue numbers for StripRight
Catalogue number Size Status
11388 In distribution
11382 In distribution
11390 In distribution
11386 In distribution
11384 In distribution
11380 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dakota Alif System Precision Spine, Inc. 53
Millennium Avalign Technologies, Inc. 32
Ambler Surgical Ambler Surgical, LLC 30
Instrument Signus Medizintechnik Gmbh 29
Stripper KLS-Martin L.P. 25
Buxton BioMedical Buxton Biomedical, Inc. 24
Boss Instruments Boss Instruments, Ltd. 18
Surtex Surtex Instruments Ltd 16
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 14
Avalign Avalign Technologies, Inc. 12
Stripper, Surgical Biomet Microfixation 12
Integra® Miltex® Integra LifeSciences Production Corporation 11

Showing 12 of 62. All products under Stripper, 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