U.S. IOL, Inc. US-7002LZV

GUDID 00814106016090

7/0 Micro Spatula, Double-Armed PGA Suture

U.S. IOL, INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00814106016090
• NIH Device Record Key: 74daea0c-fe5b-4e9d-a5f4-efbb5ddef49b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U.S. IOL, Inc.
• Version Model Number: US-7002LZV
• Catalog Number: US-7002LZV
• 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	00814106016083 [Primary]
GS1	00814106016090 [Package]; Contains: 00814106016083; 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

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

Ethylene Oxide

[00814106016090]

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

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