Home GUDID 00190660197186 Ambler Surgical
Primary DI 00190660197186
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Iris retractors
Catalog number 5161E
Device description Iris retractors, round, light brown, flexible nylon fiber, stab knife included, horizontally packaged, sterile, disposable, 1 pack of 5 retractors
Published 2021-01-04
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 HNI Retractor, ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNI Retractor, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660197186 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 00190660197186 00190660197186 190660197186 0190660197186
GMDN Terms# Term, Definition table Term Definition Intraocular retractor, single-use A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.
Regulatory Flags# DUNS number 015272206 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 00190660029340 Ambler Surgical Thornton triple vertical and 15 degree cutting edg 21-328E 2021-01-18 00190660000509 Ambler Surgical Tendon approximator 43-160 2021-01-07 00190660002121 Ambler Surgical Air injection cannula 1022E 2021-01-07 00190660002138 Ambler Surgical Air injection cannula 1328E 2021-01-07 00190660002145 Ambler Surgical Air injection cannula 1023E 2021-01-07 00190660002152 Ambler Surgical Air injection cannula 1031E 2021-01-07 00190660002169 Ambler Surgical Air injection cannula 1329E 2021-01-07 00190660002176 Ambler Surgical Air injection cannula 1026E 2021-01-07 00190660002183 Ambler Surgical Air injection cannula 1024E 2021-01-07 00190660002190 Ambler Surgical Air injection cannula 1028E 2021-01-07 00190660002206 Ambler Surgical Air injection cannula 1029E 2021-01-07 00190660002213 Ambler Surgical Air injection cannula 1027E 2021-01-07 00190660002237 Ambler Surgical Air injection cannula 1327E 2021-01-07 00190660002244 Ambler Surgical Air injection cannula 1030E 2021-01-07 00190660002268 Ambler Surgical Air injection cannula 1330E 2021-01-07 00190660002329 Ambler Surgical Alio LASIK irrigation cannula 5193E 2021-01-07 00190660002343 Ambler Surgical Anis cortex aspirating cannula 1429E 2021-01-07 00190660002350 Ambler Surgical Anis cortex aspirating cannula 1097E 2021-01-07 00190660002824 Ambler Surgical Binkhorst irrigating cannula 1332E 2021-01-07 00190660002831 Ambler Surgical Binkhorst irrigating cannula 1333E 2021-01-07
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