What is FDA product code FDA?

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticEnteroscope And Accessories

CD138 + Cyclin D1

Name: CD138 + Cyclin D1
Brand: CD138 + Cyclin D1

Catalogue number API3193DSAA, listed by Biocare Medical, LLC, United States, under Enteroscope And Accessories. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code FDA
Manufacturer	City	Province	Registered as	Device types
Dalian Create Medical Products Co., Ltd.	Dalian	Liaoning	Contract manufacturer	2

Record

Regulatory record for CD138 + Cyclin D1
Listed by	Biocare Medical, LLC, United States
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2023-06-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for CD138 + Cyclin D1
Catalogue number	Size	Status
API3193DSAA		In distribution

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Showing 12 of 19. All products under Enteroscope And Accessories

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.