JMA Optic Schütz

2 catalogue numbers from 01170020, listed by Zebris Medical Gmbh, Germany, under Device, Jaw Tracking, For Monitoring Jaw Positions. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code NFS
Manufacturer City Province Registered as Device types
Shining 3D Tech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 3

Record

Regulatory record for JMA Optic Schütz
Listed by Zebris Medical Gmbh, Germany
FDA product code NFS
Device type Device, Jaw Tracking, For Monitoring Jaw Positions
Device class Class 1
Regulation 21 CFR 872.2060
Establishment Manufacturer
Premarket notification Exempt
Record published 2020-08-19
Record revised 2021-02-19 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries manufacturing date, serial number
Storage Storage environment temperature -20 to 70 °C; Storage environment humidity 0 to 95 % RH
Distribution end date 2021-02-17

Catalogue Numbers

Catalogue numbers for JMA Optic Schütz
Catalogue number Size Status
01170020 Withdrawn
01570020 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Tech In Motion Modjaw 2
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Showing 12 of 49. All products under Device, Jaw Tracking, For Monitoring Jaw Positions

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