OPTIME®

GUDID 13661522019235

PETERS SURGICAL

Polyester suture, bioabsorbable, multifilament

• Primary Device ID: 13661522019235
• NIH Device Record Key: 8e0bd766-e082-4eea-a89d-e577c01b5efa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIME®
• Version Model Number: 18I40N
• Company DUNS: 265741780
• Company Name: PETERS SURGICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	03661522019238 [Primary]
GS1	13661522019235 [Package]; Contains: 03661522019238; Package: [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062366

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: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [OPTIME®]

• 13661522019235: 18I40N
• 13661522044510: 18S20AR
• 13661522043414: 18S30AV
• 13661522043155: 18B50D
• 13661522042363: 18S10Q
• 13661522041526: 18S07H
• 13661522041052: 18S20AP
• 13661522040987: 18R10B
• 13661522040970: 18B50C
• 13661522040963: 18B50B
• 13661522040956: 18B40D
• 13661522040949: 18B40C
• 13661522040932: 18B40B
• 13661522040925: 18B35D
• 13661522040918: 18B35C
• 13661522040901: 18B35B
• 13661522040895: 18B30D
• 13661522040888: 18B30C
• 13661522040871: 18B30B
• 13661522040864: 18B20D
• 13661522040857: 18B20C
• 13661522040840: 18B20B
• 13661522040833: 18B15D
• 13661522040826: 18B15C
• 13661522040819: 18B15B
• 13661522040802: 18B10D
• 13661522039189: 18S20AM
• 13661522039141: 18I40V
• 13661522039134: 18I35V
• 13661522039059: 18I20M
• 13661522037895: 18S30AH
• 13661522037406: 18G40F
• 13661522037390: 18G40D
• 13661522037345: 18I20AF
• 13661522035709: 18S40AT
• 13661522033255: 18S30AQ
• 13661522032951: 18N10C
• 13661522032944: 18N15C
• 13661522032937: 18N15P
• 13661522032920: 18N15F
• 13661522032913: 18N15E
• 13661522032906: 18N20B
• 13661522032890: 18N20A
• 13661522032883: 18N20R
• 13661522032876: 18N20E
• 13661522032869: 18N20D
• 13661522032852: 18N30B
• 13661522032845: 18N30A
• 13661522032838: 18N30D
• 13661522032821: 18N30F