89129

GUDID 07613252085577

Natural-Iris Conformer Color #4 Medium

Stryker Leibinger GmbH & Co. KG

Ophthalmic conformer
Primary Device ID07613252085577
NIH Device Record Key13d6bddb-a19a-4b59-83bc-aa63f21aafe9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number89129
Catalog Number89129
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter
Width26 Millimeter
Height22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613252085577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQNCONFORMER, OPHTHALMIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-24

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