Cervos Platelet Separator Triple Pack Acda

CER-PRP-Triple-A F/G, Sterile PN: 76148-01M

Registry build 21.09.26
2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1).

Chinese manufacturers registered for FDA product code ORG
Manufacturer City Province Registered as Device types
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Beijing Hanbaihan Medical Devices Co., Ltd. Beijing Beijing Contract manufacturer 4

Record

Regulatory record for Cervos Platelet Separator Triple Pack Acda
Listed by Ranfac Corp., United States
FDA product code ORG
Device type Platelet And Plasma Separator For Bone Graft Handling
Device class Class 2
Regulation 21 CFR 864.9245
Establishment Contract manufacturer, Manufacturer
510(k) BK200543
Record published 2024-04-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Avoid excessive heat. Protect from freezing. Protect from direct sunlight.; Storage environment temperature 59 to 77 °F
Packaging Case of 20
Sizes Total volume 120 ml

Catalogue Numbers

Catalogue numbers for Cervos Platelet Separator Triple Pack Acda
Catalogue number Size Status
CER-PRP-TRIPLE-A Total Volume 120 ml In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 30
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Progen PRP Eclipse Bellus Medical, LLC 8
Selphyl® Factor Medical Inc. 7
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Virtue ACKit Aeon Biotherapeutics Corp. 7
Aeon ACKit Aeon Biotherapeutics Corp. 6

Showing 12 of 119. All products under Platelet And Plasma Separator For Bone Graft Handling

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