OftalOnePack, Oftal-One

GUDID 00850074437116

Cornea recovery pack for Eye Bank

OFTAL-ONE INC.

General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00850074437116
• NIH Device Record Key: ef9e5ec5-19c9-47f0-943f-139c2276c9e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OftalOnePack, Oftal-One
• Version Model Number: PAEX 001PK
• Company DUNS: 118668232
• Company Name: OFTAL-ONE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850074437116 [Primary]

FDA Product Code

• KDD: Kit, Surgical Instrument, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-06
• Device Publish Date: 2026-02-26

On-Brand Devices [OftalOnePack, Oftal-One]

• 00850074437000: PAEX 001
• 00850074437116: Cornea recovery pack for Eye Bank
• 00850074437109: Tissue processing pack for Eye Bank
• 00850074437048: Whole globe recovery pack for Eye Bank