Primary Device ID | 00817906020038 |
NIH Device Record Key | 5a4a3625-8b45-401b-801a-bbc19e09fa25 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RTS Flexible 1st MPJ Implant w/Grommets |
Version Model Number | M30 SE040 |
Company DUNS | 079700711 |
Company Name | IN2BONES USA, 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 |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com | |
Phone | 901.260.7931 |
info@i2b-usa.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817906020038 [Primary] |
KWH | Prosthesis, Toe, Constrained, Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-11-05 |
00817906020038 | Flexible Great Toe Implant |
00817906020021 | Flexible Great Toe Implant |
00817906020014 | Flexible Great Toe Implant |
00817906020007 | Flexible Great Toe Implant |