Landers Irrigating Vitrectomy Lens Ring

GUDID 00630238007894

OCULAR INSTRUMENTS, INC.

Vitrectomy sutureless lens holding ring, reusable

• Primary Device ID: 00630238007894
• NIH Device Record Key: 857088d0-2946-4320-949a-489dbabe3507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Landers Irrigating Vitrectomy Lens Ring
• Version Model Number: OLV-1-IR
• Company DUNS: 046212387
• Company Name: OCULAR INSTRUMENTS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238007894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902496

FDA Product Code

• HNH: Ring, Ophthalmic (Flieringa)

Sterilization

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

[00630238007894]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-19
• Device Publish Date: 2019-06-11

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• 00630238084741 - MaxAC® Lens Stand: 2019-09-10
• 00063023800712 - Ritch Trabeculoplasty Laser Lens: 2019-06-20
• 00630238006972 - Koeppe Extra Small Diagnostic Lens 12mm O.D.: 2019-06-20
• 00630238007092 - Single Mirror Kaufman Laser Lens: 2019-06-20
• 00630238008075 - Koeppe Large Diagnostic Lens 19mm O.D.: 2019-06-20