Aesculap

PERKINS Wound Retractor, self-retaining, 5", (125 mm), serrated (coarse), solid blade right, non-sterile, reusable

Registry build 21.09.26
3manufacturers in China registered for this device type
46catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1).

Chinese manufacturers registered for FDA product code KAL
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Wilpower Industrial Co., Ltd. Shanghai Shanghai Exporter 33

Record

Regulatory record for Aesculap
Listed by Aesculap AG, Germany
FDA product code KAL
Device type Retractor, Ent
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-05-07
Record revised 2023-08-24 (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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Status
MA424R In distribution
OM111R In distribution
MA430R In distribution
MA433R In distribution
OM114R In distribution
OM175R In distribution
OM112R In distribution
OK794R In distribution
MG810R In distribution
OL219R In distribution
BV093R In distribution
MA438R In distribution
OK795R In distribution
MA426R In distribution
OM253R In distribution
OM252R In distribution
MA428R In distribution
MA432R In distribution
BT120R In distribution
MA431R In distribution
OM174R In distribution
OM178R In distribution
OL210R In distribution
OM176R In distribution
MA422R In distribution
MA423R In distribution
OM172R In distribution
MB107R In distribution
MA427R In distribution
MA608R In distribution
OM182R In distribution
OL220R In distribution
MA429R In distribution
OM173R In distribution
MB748R In distribution
OL221R In distribution
OK103R In distribution
OM177R In distribution
MB054R In distribution
OM115R In distribution
OM181R In distribution
OM113R In distribution
OM183R In distribution
OM171R In distribution
MG659R In distribution
OM251R In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
V. Mueller Steris Corporation 138
Ambler Surgical Ambler Surgical, LLC 105
Pilling Teleflex Medical LLC 90
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 89
Boss Instruments Boss Instruments, Ltd. 61
Avalign Avalign Technologies, Inc. 54
Fentex Fentex medical GmbH 54
Novo Surgical Novo Surgical, Inc. 52
Millennium Avalign Technologies, Inc. 47
MSI Precision Specialty Instruments MED Saver, Inc. 43
Novo Surgical Inc. Novo Surgical, Inc. 42
HNM Medical HNM Stainless, LLC. 39

Showing 12 of 80. All products under Retractor, Ent

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