MONO Q

GUDID 10812444021162

SUTURE

RIVERPOINT MEDICAL, LLC

Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture Poliglecaprone suture

• Primary Device ID: 10812444021162
• NIH Device Record Key: 2b1969ed-b6dd-4ade-84b6-6f3d0f389c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONO Q
• Version Model Number: Q346
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, LLC
• 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: 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	00812444021165 [Primary]
GS1	10812444021162 [Package]; Contains: 00812444021165; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100461

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

On-Brand Devices [MONO Q]

• 00812444025798: SUTURE
• 10812444024705: SUTURE
• 00812444024654: SUTURE
• 10812444024644: SUTURE
• 10812444024101: SUTURE
• 10812444024095: SUTURE
• 10812444024088: SUTURE
• 10812444024071: SUTURE
• 10812444024064: SUTURE
• 10812444024057: SUTURE
• 10812444024040: SUTURE
• 10812444024033: SUTURE
• 10812444024026: SUTURE
• 10812444024019: SUTURE
• 10812444024002: SUTURE
• 10812444023999: SUTURE
• 10812444023982: SUTURE
• 00812444023169: SUTURE
• 10812444021339: SUTURE
• 10812444021322: SUTURE
• 10812444021315: SUTURE
• 10812444021308: SUTURE
• 10812444021292: SUTURE
• 10812444021285: SUTURE
• 10812444021278: SUTURE
• 10812444021261: SUTURE
• 10812444021254: SUTURE
• 10812444021247: SUTURE
• 10812444021230: SUTURE
• 10812444021223: SUTURE
• 10812444021216: SUTURE
• 10812444021209: SUTURE
• 10812444021193: SUTURE
• 10812444021186: SUTURE
• 10812444021179: SUTURE
• 10812444021162: SUTURE
• 10812444021155: SUTURE
• 10812444021148: SUTURE
• 00812444021134: SUTURE
• 10812444021124: SUTURE
• 00812444021110: SUTURE
• 10810020085294: Suture
• 10810020085010: Suture
• 10810020084990: Suture
• 10810020084921: Suture
• 10810020084808: Suture
• 10810020084792: Suture
• 10810020087717: Suture
• 10810020087700: Suture
• 10810020087694: Suture