Primary Device ID | 00812444026245 |
NIH Device Record Key | f65c4481-4322-4a6e-88e1-0bbec1127e96 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OrthoButton AL |
Version Model Number | RP-OBAL-80 |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812444026245 [Primary] |
GS1 | 10812444026242 [Package] Package: [10 Units] In Commercial Distribution |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-05-29 |
Device Publish Date | 2017-11-07 |
00812444026245 | Suture Button Loop |
00812444026986 | Soft tissue fixation device |
10840277402964 | Suture Button Loop |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOBUTTON AL 87364863 5322227 Live/Registered |
RIVERPOINT MEDICAL, LLC 2017-03-09 |