Home GUDID M872191240 Bilateral Conformer 16 Regular
Primary DI M872191240
Brand Bilateral Conformer 16 Regular
Company Oculo-Plastik Inc
Model 19-124
Device description Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye).The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Published 2017-02-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HQN Conformer, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HQN Conformer, Ophthalmic Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M872191240 Previous HIBCC 0 10697660001194 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10697660001194 10697660001194
GMDN Terms# Term, Definition table Term Definition Ophthalmic conformer An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 1.8 Millimeter Length 26 Millimeter Width 25.5 Millimeter
Sterilization Methods# Method table Method "[""Ethylene Oxide"", ""Hydrogen Peroxide""]" Ethylene Oxide;Hydrogen Peroxide Hydrogen Peroxide;Ethylene Oxide
Regulatory Flags# DUNS number 257382580 Device count 1 Premarket exempt 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 10697660003617 Autoclavable Plastic Sterilisation Tray with mat, large 27-1006151 2019-11-28 10697660003631 Autoclavable Plastic Sterilisation Tray with mat 27-100675 2019-11-28 10697660003686 Autoclavable Plastic Sterilisation Tray with mat, medium 27-6545 2019-11-11 10697660003679 Autoclavable Plastic Sterilisation Tray with mat, small 27-6530 2019-11-07 10697660002191 David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare) 21-322 2019-11-18 10697660002207 David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb. 21-322R 2019-11-18 10697660002221 David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare) 21-323 2019-11-18 10697660002245 David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare), refurb 21-323R 2019-11-18 M87221416V95 Symblepharon Ring Conformer Large, In Bulk 21-416V 2016-10-16 10697660001903 Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb . 21-275R 2019-11-21 10697660001927 Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb. 21-276R 2019-11-21 10697660001965 Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb. 21-287R 2019-11-21 10697660001989 Laser SWAB SS Tissue Handler And Backstop for Laser (non glare) 21-289 2019-11-21 10697660001996 Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb. 21-289R 2019-11-21 10697660002023 Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb. 21-292R 2019-11-21 10697660002047 Jaeger SS Lid Plate for the Laser (non glare), refurb. 21-295R 2019-11-21 10697660003297 Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends 23-293Y 2019-11-25 10697660003310 Plastic Jaeger lid plates, t-yellow flater model with medium & large ends 23-295Y 2019-11-25 10697660003334 Desmarres, Autoclavable plastic retractor t-yellow 23-311Y 2019-11-25 10697660003341 Desmarres, Autoclavable plastic retractor t-yellow 23-315Y 2019-11-25
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