Remanium®

remanium® Goshgarian palatal bars assortment / For further information please visit our online-shop on our website www.dentaurum.de

Registry build 21.09.26
2manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code EHO
Manufacturer City Province Registered as Device types
Foshan Nanhai Hongchen Medical Equipments Co., Ltd. Foshan Guangdong Manufacturer 11
Zhuhai DS Dental Technology Co., Ltd. Zhuhai Guangdong Manufacturer 8

Record

Regulatory record for remanium®
Listed by Dentaurum GmbH & Co. KG, Germany
FDA product code EHO
Device type Bar, Preformed
Device class Class 1
Regulation 21 CFR 872.3165
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-15
Record revised 2021-02-05 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Storage Special storage condition: No special storage conditions required

Catalogue Numbers

Catalogue numbers for remanium®
Catalogue number Size Per pack Status
728-501-00 5 In distribution
728-503-00 5 In distribution
728-100-01 10 In distribution
728-007-00 10 In distribution
728-024-00 10 In distribution
728-015-00 10 In distribution
728-008-00 10 In distribution
728-006-00 10 In distribution
728-005-00 10 In distribution
728-023-00 10 In distribution
728-502-00 5 In distribution
728-020-00 In distribution
728-500-00 In distribution
728-022-00 10 In distribution
728-102-01 10 In distribution
728-021-00 10 In distribution
728-025-00 10 In distribution
728-013-00 10 In distribution
728-101-01 10 In distribution
728-505-00 5 In distribution
728-504-00 5 In distribution
728-014-00 10 In distribution
728-026-00 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Preat Preat Corporation 61
Pathfinder NXT Minimally Invasive Pedicle Screw System Institut Straumann AG 37
Bar, Preformed Dentaurum GmbH & Co. KG 14
Bar, Preformed Stryker Leibinger Gmbh & Co. KG 6
Nobil Metal SPA Nobil Metal SPA 6
Hader Bar Preat Corporation 6
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 3
Bar, Preformed Institut Straumann AG 2
V. Mueller Steris Corporation 1
Hader Preat Corporation 1
Universal IC Attachment Preat Corporation 1
Millennium Avalign Technologies, Inc. 1

Showing 12 of 15. All products under Bar, Preformed

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