Symmetry Olsen 607000

GUDID 30841785107703

OLSEN MEDICAL, LLC

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• Primary Device ID: 30841785107703
• NIH Device Record Key: e4e9fe38-e8cd-4a59-9805-88617f3eafd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetry Olsen
• Version Model Number: 607000
• Catalog Number: 607000
• Company DUNS: 079344210
• Company Name: OLSEN MEDICAL, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841785107702 [Primary]
GS1	30841785107703 [Package]; Contains: 00841785107702; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852404

FDA Product Code

• HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

On-Brand Devices [Symmetry Olsen]

• 00841785113345: 08-0005I
• 00841785113338: 08-0047I
• 00841785113321: 08-0090
• 00841785113314: 08-0021
• 00841785113277: 08-0320I
• 00841785113260: 08-0313I
• 00841785113253: 08-0313
• 00841785113246: 08-0310I
• 00841785113239: 08-0310
• 00841785113222: 08-0307I
• 00841785113215: 08-0306I
• 00841785113208: 08-0305I
• 00841785113192: 08-0304I
• 00841785113185: 08-0303I
• 00841785113178: 08-0302I
• 00841785113161: 08-0301I
• 00841785113147: 08-0099I
• 00841785113130: 08-0019I
• 00841785113123: 08-0019
• 00841785113116: 08-0017I
• 00841785113109: 08-0320
• 00841785113093: 08-0319
• 00841785113086: 08-0316I
• 00841785113079: 08-0312I
• 00841785113062: 08-0312
• 00841785113055: 08-0311I
• 00841785113048: 08-0311
• 00841785113031: 08-0309I
• 00841785113024: 08-0309
• 00841785113017: 08-0308I
• 00841785113000: 08-0308
• 00841785112997: 08-0307
• 00841785112980: 08-0306
• 00841785112973: 08-0305
• 00841785112966: 08-0304
• 00841785112959: 08-0303
• 00841785112942: 08-0302
• 00841785112935: 08-0301
• 00841785112928: 08-0300
• 00841785112911: 08-0223
• 00841785112904: 08-0204
• 00841785112898: 08-0203
• 00841785112881: 08-0152
• 00841785112843: 08-0099
• 00841785112836: 08-0091I
• 00841785112829: 08-0091
• 00841785112812: 08-0089I
• 00841785112805: 08-0089
• 00841785112799: 08-0044
• 00841785112782: 08-0043I