Home GUDID 00190660104801 Ambler Surgical
Primary DI 00190660104801
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Hoffer optic zone marker
Catalog number 8242E
Device description Hoffer optic zone marker, 4 1/4'', 3.50mm diameter, with cross hairs, round handle
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 false
Single use false Product Codes# Code, Name table Code Name HMR Marker, ocular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HMR Marker, Ocular Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660104801 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 00190660104801 00190660104801 190660104801 0190660104801
GMDN Terms# Term, Definition table Term Definition Scleral marker, reusable A manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true 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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