OPTIME R®

GUDID 03661522101476

PETERS SURGICAL

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 03661522101476
• NIH Device Record Key: 34e5e87f-56e8-4259-bd74-47bd0134969b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIME R®
• Version Model Number: 12S20T
• Company DUNS: 265741780
• Company Name: PETERS SURGICAL
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661522101476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233265

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

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: 2026-03-17
• Device Publish Date: 2026-03-09

On-Brand Devices [OPTIME R®]

• 03661522101513: 12S30V
• 03661522101506: 12S30U
• 03661522101490: 12S20V
• 03661522101483: 12S20U
• 03661522101476: 12S20T
• 03661522101469: 12S20S
• 03661522101452: 12S15V
• 03661522101445: 12S15U
• 03661522101438: 12S10H
• 03661522101421: 12S10F
• 03661522101414: 12S07C