MONO Q
GUDID 10812444023999
SUTURE
RIVERPOINT MEDICAL, LLC
Poliglecaprone suture| Primary Device ID | 10812444023999 |
| NIH Device Record Key | 4b25cdb8-f595-4e8f-b04b-2df7dd722bcb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONO Q |
| Version Model Number | Q304 |
| 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 | 00812444023992 [Primary] |
| GS1 | 10812444023999 [Package] Contains: 00812444023992 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 | 2015-10-24 |
On-Brand Devices [MONO Q]
Trademark Results [MONO Q]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MONO Q 86510082 4777286 Live/Registered |
GE HEALTHCARE BIOPROCESS R&D AB 2015-01-21 |
 MONO Q 85392445 4114963 Live/Registered |
RIVERPOINT MEDICAL, LLC 2011-08-08 |
 MONO Q 73462558 1311779 Live/Registered |
Pharmacia AB 1984-01-24 |
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