Aesculap

Root Elevator, straight, 6", (150 mm), handle with thumb depression, Fig. 1S, width: 4,500 mm, non-sterile, reusable

Registry build 21.09.26
6manufacturers in China registered for this device type
86catalogue 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 EMJ
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
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for Aesculap
Listed by Aesculap AG, Germany
FDA product code EMJ
Device type Elevator, Surgical, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-04-20
Record revised 2023-08-25 (version 5)

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 2022-03-09
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Status
DL366R In distribution
DL272R In distribution
DL032R In distribution
DL062R In distribution
DO575R In distribution
DO642R In distribution
DL229R In distribution
DL427R In distribution
DO543R In distribution
DL241R In distribution
DL428R In distribution
DL362R In distribution
DB850R In distribution
DL211R In distribution
DL364R In distribution
DL230R In distribution
DL373R In distribution
DL015R In distribution
DL047R In distribution
DL038R In distribution
DL225R In distribution
DL034R In distribution
DL242R In distribution
DL236R In distribution
DO546R In distribution
DL422R In distribution
MA143R In distribution
DO501R In distribution
DL222R In distribution
DL239R In distribution
DO510R In distribution
DL410R In distribution
DL243R In distribution
DL212R In distribution
DL375R In distribution
DO520R In distribution
DL271R In distribution
DL409R In distribution
DL027R In distribution
DL069R In distribution
DL221R In distribution
DL025R In distribution
DO803R In distribution
DO577R In distribution
DL055R In distribution
DL026R In distribution
DL028R In distribution
DB827R In distribution
DL046R In distribution
DL063R In distribution
DO572R In distribution
DL371R In distribution
DL056R In distribution
DL421R In distribution
DL052R In distribution
DL264R In distribution
DL365R In distribution
DO502R In distribution
DL376R In distribution
DL237R In distribution
DO525R In distribution
DO573R In distribution
DL370R In distribution
DL363R In distribution
DL360R In distribution
DL361R In distribution
DL011R In distribution
DL020R In distribution
DO801R In distribution
DB828R In distribution
DL050R In distribution
DL372R In distribution
DO503R In distribution
DO518R In distribution
DL238R In distribution
DL226R In distribution
DL057R In distribution
DO547R In distribution
DL374R In distribution
DL033R In distribution
DO802R In distribution
DO571R In distribution
DO574R In distribution
DO328R Withdrawn
DO612R Withdrawn
DB826R Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 465
Nordent Manufacturing Inc Nordent Manufacturing Inc 264
Power Dental USA Power Dental U.S.A. Inc. 247
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 233
Elevator KLS-Martin L.P. 231
Kohdent Kohler Medizintechnik GmbH 206
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 153
Stoma® Storz AM Mark Gmbh 150
Reicodent Devemed Gmbh 142
Sklar Sklar Corporation 130
Osung MND Osung MND Co., Ltd. 126
Karl Schumacher Karl Schumacher Dental, LLC 121

Showing 12 of 743. All products under Elevator, Surgical, Dental

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