89128

GUDID 07613252085560

Natural-Iris Conformer Color #3 Medium

Stryker Leibinger GmbH & Co. KG

Ophthalmic conformer

• Primary Device ID: 07613252085560
• NIH Device Record Key: c996f405-ed6f-4c94-8c7f-66aecfad6966
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 89128
• Catalog Number: 89128
• 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

• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter
• Height: 22 Millimeter
• Width: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252085560 [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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• 07613327401738 - NA: 2025-01-17 SternalPlate, T
• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm