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

TG-98 LM Synea 400

Name: TG-98 LM Synea 400
Brand: TG-98 LM Synea 400

Catalogue number 30003002, listed by W&H Dentalwerk Bürmoos GmbH, Austria, 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 TG-98 LM Synea 400
Listed by	W&H Dentalwerk Bürmoos GmbH, Austria
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Record published	2018-08-31
Record revised	2025-06-11 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	manufacturing date, serial number
Distribution end date	2025-06-10

Catalogue Numbers

Catalogue numbers for TG-98 LM Synea 400
Catalogue number	Size	Status
30003002		Withdrawn

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HealthMart	Strategic Sourcing Services LLC	1
Ancora	Aspero Medical, 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.