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

ProWorks

Name: ProWorks
Brand: ProWorks

ProWorks® GrizzlyNite® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 5 mil, X-Small, 100/bx, 10 bxs/cs

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 ProWorks
Listed by	Tranzonic Companies, THE
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Record published	2020-04-02
Record revised	2023-06-14 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes

Catalogue Numbers

Catalogue numbers for ProWorks
Catalogue number	Size	Per pack	Status
GL-N105FXS		100	In distribution

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CD138 + Cyclin D1	Biocare Medical, LLC	1
HealthMart	Strategic Sourcing Services LLC	1
TG-98 LM Synea 400	W&H Dentalwerk Bürmoos GmbH	1
Ancora	Aspero Medical, Inc.	1
Zeus-P	Spinal Elements, Inc.	1
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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.