Primary Device ID | M695M1901011S0 |
NIH Device Record Key | c471f373-0fed-4d81-a029-a8dad82e0b84 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FuseFix Hammertoe |
Version Model Number | M19-01011-S |
Catalog Number | M19-01011-S |
Company DUNS | 010968002 |
Company Name | Tyber Medical LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M695M1901011S0 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-13 |
Device Publish Date | 2020-01-03 |
M695M1901011S0 | Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6”) Kit |
M695M1901009S0 | Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6”) Kit |
M695M1901000S0 | Mini Fixed AO Handle |
M695M13S30115S0 | FuseFix Solid 10° Ø3.0mm x 15mm |
M695M13S30015S0 | FuseFix Solid 0° Ø3.0mm x 15mm |
M695M13S25115S0 | FuseFix Solid 10° Ø2.5mm x 15mm |
M695M13S25115D0 | Demo FuseFix Solid 10° Ø2.5mm x 15mm |
M695M13S25015S0 | FuseFix Solid 0° Ø2.5mm x 15mm |
M695M13S25015D0 | Demo FuseFix Solid 0° Ø2.5mm x 15mm |
M695M13S20113S0 | FuseFix Solid 10° Ø2.0mm x 13mm |
M695M13S20013S0 | FuseFix Solid 0° Ø2.0mm x 13mm |
M695M13C30015S0 | FuseFix Cannulated Ø3.0mm x 15mm |
M695M13C25015S0 | FuseFix Cannulated Ø2.5mm x 15mm |
M695M13C25015D0 | Demo FuseFix Cannulated Ø2.5mm x 15mm |
M695M13C20013S0 | FuseFix Cannulated Ø2.0mm x 13mm |