Surgical Direct

MicroFrance Pediatric Backbiter, Curved Down Overall Length 105mm Working Length 80mm 1.5mm x 3.0mm Bite Working Length 80mm 1.5mm x 3.0mm Bite

Registry build 21.09.26
11manufacturers in China registered for this device type
1,208catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTX
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
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
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Qingdao Zhixing Medical Instrument Co., Ltd. Qingdao Shandong Manufacturer 6

Record

Regulatory record for Surgical Direct
Listed by Surgical Direct, Inc., United States
FDA product code HTX
Device type Rongeur
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2022-12-01
Record revised 2025-05-02 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number
Distribution end date 2025-05-02

Catalogue Numbers

Catalogue numbers for Surgical Direct
Catalogue number Size Status
SD92381415 In distribution
SDI06004D In distribution
SD921202136 In distribution
SD922766070 In distribution
SD92274310 In distribution
SD91481110 In distribution
S22745.100 In distribution
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SD48-6133 In distribution
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SD922813203 In distribution
SDG12519 In distribution
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SD77510-15 In distribution
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Showing 250 of 300 catalogue numbers.

Same Product Code

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Product Sold by Catalogue numbers
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MSI Precision Specialty Instruments MED Saver, Inc. 244
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HNM Medical HNM Stainless, LLC. 186
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 180

Showing 12 of 438. All products under Rongeur

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