U.S. IOL, Inc. US-8002LZV

GUDID 00814106016113

8/0 Micro Spatula, Double-Armed PGA Suture

U.S. IOL, INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00814106016113
• NIH Device Record Key: c6e111f9-1fe9-4891-897c-5b7bfbb559ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U.S. IOL, Inc.
• Version Model Number: US-8002LZV
• Catalog Number: US-8002LZV
• 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
• 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 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814106016106 [Primary]
GS1	00814106016113 [Package]; Contains: 00814106016106; Package: Box of 12 [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140039

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

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

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

[00814106016113]

Ethylene Oxide

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.]

• 00814106016151: 8/0 Micro Spatula, Double-Armed Silk Suture
• 00814106016137: 9/0 Micro Spatula, Double-Armed PGA Suture
• 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%