Stoma®

Periosteal elevator, Palti / Molt, 8mm / 11mm, with hole, DE

Registry build 21.09.26
6manufacturers in China registered for this device type
150catalogue 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 Stoma®
Listed by Storz AM Mark Gmbh, 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, Manufacturer
Premarket notification Exempt
Record published 2020-08-27
Record revised 2020-12-04 (version 2)

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

Catalogue Numbers

Catalogue numbers for Stoma®
Catalogue number Size Per pack Status
14431.00 In distribution
14610.01 In distribution
1111.03 In distribution
1047.00 In distribution
1165.00 In distribution
14610.02 In distribution
14421.02 In distribution
14446.03 In distribution
14435.00 In distribution
1189.15 In distribution
14610.07 In distribution
14421.01 In distribution
14608.01 In distribution
4422.08 In distribution
14425.00 In distribution
14437.06 In distribution
14610.11 In distribution
14446.04 In distribution
14413.00 In distribution
1304.00 In distribution
1069.00 In distribution
1007.00 In distribution
1230.00 In distribution
4418.06 In distribution
14402.01 In distribution
1040.01 In distribution
14421.06 In distribution
14610.03 In distribution
1231.00 In distribution
14611.08 In distribution
1111.02 In distribution
14446.22 In distribution
14447.01 In distribution
14401.00 In distribution
1012.00 In distribution
1144.00 In distribution
1228.00 In distribution
1040.07 In distribution
14442.00 In distribution
14416.00 In distribution
1212.10 In distribution
14446.25 In distribution
4426.05 In distribution
1275.00 In distribution
14446.21 In distribution
4425.10 In distribution
4425.08 In distribution
1277.00 In distribution
1305.00 In distribution
14611.04 In distribution
14422.00 In distribution
1274.00 In distribution
1110.02 In distribution
14610.06 In distribution
1237.01 In distribution
1323.00 In distribution
1192.01 In distribution
14447.02 In distribution
14611.10 In distribution
1164.00 In distribution
1192.03 In distribution
14610.04 In distribution
14608.02 In distribution
1037.00 In distribution
1090.40 In distribution
4412.04 In distribution
1212.08 In distribution
1011.00 In distribution
14446.01 In distribution
14419.03 In distribution
1036.00 In distribution
14611.07 In distribution
14610.12 In distribution
1090.50 In distribution
1090.31 In distribution
14423.00 In distribution
14439.00 In distribution
1038.00 In distribution
1111.04 In distribution
14421.25 In distribution
1027.00 In distribution
14438.00 In distribution
1090.51 In distribution
1192.04 In distribution
1306.00 In distribution
1048.00 In distribution
14424.00 In distribution
14447.03 2 In distribution
1090.41 In distribution
1191.03 In distribution
1276.00 In distribution
14611.09 In distribution
14447.04 3 In distribution
14446.23 In distribution
1040.06 In distribution
1104.00 In distribution
1273.00 In distribution
4411.00 In distribution
1236.01 In distribution
1189.22 In distribution
14446.02 In distribution
1303.00 In distribution
1271.00 In distribution
14418.00 In distribution
1062.41 In distribution
1189.18 In distribution
1026.00 In distribution
4418.08 In distribution
4423.00 In distribution
14414.00 In distribution
1237.00 In distribution
14421.03 In distribution
1040.21 In distribution
14437.08 In distribution
1272.00 In distribution
1103.00 In distribution
14434.00 In distribution
1090.30 In distribution
1110.03 In distribution
14445.00 In distribution
1062.04 In distribution
14610.05 In distribution
14611.03 In distribution
1279.00 In distribution
1006.00 In distribution
4426.03 In distribution
14608.03 In distribution
1227.00 In distribution
14611.06 In distribution
14672.00 In distribution
14610.08 In distribution
1110.04 In distribution
1063.04 In distribution
1192.02 In distribution
1145.00 In distribution
4412.06 In distribution
1067.00 In distribution
14436.00 In distribution
1236.00 In distribution
14425.03 In distribution
1008.00 In distribution
1278.00 In distribution
14438.01 In distribution
1013.00 In distribution
1068.00 In distribution
1322.00 In distribution
14446.24 In distribution
1028.00 In distribution
14415.00 In distribution
14419.05 In distribution

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
Reicodent Devemed Gmbh 142
Sklar Sklar Corporation 130
Osung MND Osung MND Co., Ltd. 126
Karl Schumacher Karl Schumacher Dental, LLC 121
Elevator, Surgical, Dental Biomet Microfixation 120

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