U.S. IOL, Inc. U-BLUE

GUDID 00803878044721

U-BLUE Trypan Blue Solution 0.06%

U.S. IOL, INC.

Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye Ophthalmic surgical dye

• Primary Device ID: 00803878044721
• NIH Device Record Key: 1d9da62a-77b2-4835-a0a3-618c149014c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U.S. IOL, Inc.
• Version Model Number: U-BLUE
• Catalog Number: U-BLUE
• Company DUNS: 604739490
• Company Name: U.S. IOL, 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com
• Phone: +1(859)259-4925
• Email: usiol@aol.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803878044721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024090

FDA Product Code

• GAR: Suture, nonabsorbable, synthetic, polyamide

Sterilization

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

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

[00803878044721]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-30
• Device Publish Date: 2020-09-22

On-Brand Devices [U.S. IOL, Inc.]

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• 00814106016113: 8/0 Micro Spatula, Double-Armed PGA Suture
• 00814106016090: 7/0 Micro Spatula, Double-Armed PGA Suture
• 00814106016076: 6/0 Side Cutting Spatula, Double-Armed PGA Suture
• 00814106016052: 10/0 Micro Spatula, Double-Armed Nylon Suture
• 00814106016038: 10/0 Micro Spatula, Double-Armed Nylon Suture
• 00814106016014: 9/0 Micro Spatula, Double-Armed Nylon Suture
• 00814106015994: 8/0 Micro Spatula, Double-Armed Nylon Suture
• 00814106015970: 7/0 Taper Point, Double-Armed Nylon Suture
• 00814106015956: 6/0 Micro Spatula, Double-Armed Nylon Suture
• 00803878044721: U-BLUE Trypan Blue Solution 0.06%