Home GUDID 00190660174996 Ambler Surgical
Primary DI 00190660174996
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model DSAEK descemet's membrane stripper
Catalog number 2123E
Device description DSAEK descemet's membrane stripper, irrigating version, 5'', 11.0mm from bend to tip, angled 45 degrees interchangeable tip, supplied with #2121E tip and #2120E handle
Published 2021-01-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HND Spatula, ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HND Spatula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660174996 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190660174996 00190660174996 190660174996 0190660174996
GMDN Terms# Term, Definition table Term Definition Ocular hook/spatula/manipulator, reusable A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 Device count 1 Premarket exempt true Kit true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00190660100360 Ambler Surgical Fiberoptic light cable 40-800 2021-01-04 00190660100377 Ambler Surgical Fiberoptic light cable 40-500 2021-01-04 00190660100384 Ambler Surgical Fiberoptic light cable 40-810 2021-01-04 00190660100391 Ambler Surgical Fiberoptic light cable 40-505 2021-01-04 00190660100407 Ambler Surgical Fiberoptic light cable 40-820 2021-01-04 00190660100414 Ambler Surgical Fiberoptic light cable 40-830 2021-01-04 00190660100421 Ambler Surgical Fiberoptic light cable 40-510 2021-01-04 00190660100438 Ambler Surgical Fiberoptic light cable 40-515 2021-01-04 00190660100445 Ambler Surgical Fiberoptic light cable 40-520 2021-01-04 00190660100452 Ambler Surgical Fiberoptic light cable 40-525 2021-01-04 00190660100469 Ambler Surgical Fiberoptic light cable 40-530 2021-01-04 00190660100476 Ambler Surgical Fiberoptic light cable 40-535 2021-01-04 00190660100483 Ambler Surgical Fiberoptic light cable 40-840 2021-01-04 00190660100490 Ambler Surgical Fiberoptic light cable 40-850 2021-01-04 00190660100506 Ambler Surgical Fiberoptic light cable 40-860 2021-01-04 00190660100513 Ambler Surgical Fiberoptic light cable 40-540 2021-01-04 00190660100520 Ambler Surgical Fiberoptic light cable 40-600 2021-01-04 00190660100537 Ambler Surgical Fiberoptic light cable 40-610 2021-01-04 00190660100544 Ambler Surgical Fiberoptic light cable 40-100 2021-01-04 00190660100551 Ambler Surgical Fiberoptic light cable 40-620 2021-01-04
Other Devices Sharing Product Codes# 
amblersurgical.com