Aesculap

CUSHING Rongeur, 150 °, downwards cutting, 5 1/2" (140 mm), serrated, lower part of jaw movable, 4 x 14 mm

Registry build 21.09.26
11manufacturers in China registered for this device type
264catalogue 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 Aesculap
Listed by Aesculap AG, Germany
FDA product code HTX
Device type Rongeur
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-05-08
Record revised 2022-07-14 (version 4)

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
Distribution end date 2025-10-28
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Status
FH891B In distribution
FF562R In distribution
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FO514R In distribution
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Showing 250 of 264 catalogue numbers.

Same Product Code

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Product Sold by Catalogue numbers
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gSource Gsource, LLC. 509
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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