Level ONE, Sterile

Battery Pack, FOR 50-800-0X-07, Alkaline

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MOQ
Manufacturer City Province Registered as Device types
Polyrack Science & Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 1

Record

Regulatory record for Level ONE, Sterile
Listed by KLS-Martin L.P., United States
FDA product code MOQ
Device type Battery, Replacement, Rechargeable
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-09-26
Record revised 2024-08-23 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Level ONE, Sterile
Catalogue number Size Status
50-800-02-71 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Interstate All Battery Interstate All Battery Center 157
Anybattery Anybattery, Inc 140
Artisan Power Artisan Power LLC 92
Battery, Replacement, Rechargeable Synthes Gmbh 17
Zimmer Biomet™ Zimmer Surgical, Inc. 9
MicroAire® Microaire Surgical Instruments LLC 4
Acculan Aesculap AG 4
Bioseal Inc. Bioseal 4
Hall ConMed Corporation 4
Acculan II Aesculap AG 3
Unium Synthes Gmbh 3
Powerpro ConMed Corporation 2

Showing 12 of 27. All products under Battery, Replacement, Rechargeable

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