89132

GUDID 07613252085607

Natural-Iris Conformer Color #1 Large

Stryker Leibinger GmbH & Co. KG

Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer

Primary Device ID	07613252085607
NIH Device Record Key	799e9f04-4762-47c9-9b38-6a193afa9014
Commercial Distribution Status	In Commercial Distribution
Version Model Number	89132
Catalog Number	89132
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter
Width	28 Millimeter
Height	24 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252085607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K972034

FDA Product Code

HQN	CONFORMER, OPHTHALMIC

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-08-24

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