Home GUDID 14897106954008 andorate® Biopsy Valve
Primary DI 14897106954008
Brand andorate® Biopsy Valve
Company GA Health Company Limited
Model GAR018-S
Published 2022-01-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name ODC Endoscope Channel Accessory
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODC Endoscope Channel Accessory Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14897106954008 Package GS1 100 In Commercial Distribution 24897106954005 Package GS1 10 In Commercial Distribution 04897106954001 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14897106954008 14897106954008 24897106954005 24897106954005 04897106954001 04897106954001 4897106954001
GMDN Terms# Term, Definition table Term Definition Endoscopic biopsy valve, single-use A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.
Regulatory Flags# DUNS number 686908512 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04897106955060 Four Chamber Polyp Trap (Non-sterile) EN10103.4 2022-03-25 04897106955091 Single Chamber Polyp Trap (Non-sterile) EN10113.1 2022-03-25 04897106956081 andorate® ThomasTrap ™ Polyp Trap 2.0 GAR104040 2026-03-18 04897106958566 andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit 101047 2026-03-18 04897106958573 andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit 101048 2026-03-18 04897106958597 andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit 101067 2026-03-18 04897106958603 andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit 101068 2026-03-18 04897106957880 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit 101049 2026-03-13 04897106957897 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit 101050 2026-03-13 04897106957941 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit 101069 2026-03-13 04897106957958 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit 101070 2026-03-13 04897106958016 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit 101095 2026-03-13 04897106958023 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit 101096 2026-03-13 14897106957887 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit 101049 2026-03-13 14897106957894 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit 101050 2026-03-13 14897106957948 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit 101069 2026-03-13 14897106957955 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit 101070 2026-03-13 14897106958013 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit 101095 2026-03-13 14897106958020 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit 101096 2026-03-13 04897106957910 andorate® 4-piece valve kit 101066 2026-03-12
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