Primary Device ID | 10812444021865 |
NIH Device Record Key | b704d690-bf3c-4d38-8343-b55580ab7386 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RIVERBOND |
Version Model Number | PB683 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00812444021868 [Primary] |
GS1 | 10812444021865 [Package] Contains: 00812444021868 Package: [12 Units] In Commercial Distribution |
GAS | Suture, Nonabsorbable, Synthetic, Polyester |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-02-07 |
Device Publish Date | 2015-10-16 |
00840277405579 - RootMend™ MRR (Black) | 2025-05-09 Adjustable Loop |
00840277405586 - RootMend™ MRR (Blue) | 2025-05-09 Adjustable Loop |
00840277405593 - RootMend™ MRR | 2025-05-09 Titanium Button |
00840277405647 - RootMend™ MRR Soft Button (Black) | 2025-05-09 Adjustable Loop |
00840277405654 - RootMend™ MRR Soft Button (Blue) | 2025-05-09 Adjustable Loop |
00840277402196 - PERMACORD™ Stiffened Suture | 2025-05-06 Size 2 Stiffened Suture Blue, UHMWPE Non-absorbable Suture |
00840277402219 - PERMACORD™ Stiffened Suture | 2025-05-06 Size 2 Stiffened Suture White/Blue, UHMWPE Non-absorbable Suture |
00840277402233 - PERMALOOP™ MINI Stiffened Suture | 2025-05-06 1.4mm Stiffened Suture Tape w/ Looped End Blue, UHMWPE Non-absorbable Suture |