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

Set, Administration, Intravascular

Name: Set, Administration, Intravascular
Brand: Set, Administration, Intravascular

Catalogue number EB-060-26, listed by Life Science Outsourcing, Inc., 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 Set, Administration, Intravascular
Listed by	Life Science Outsourcing, Inc., United States
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Record published	2017-03-29
Record revised	2020-02-07 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Distribution end date	2020-02-06

Catalogue Numbers

Catalogue numbers for Set, Administration, Intravascular
Catalogue number	Size	Status
EB-060-26		Withdrawn

Same Product Code

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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
Jade PTA Balloon Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	1

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.