Primary Device ID | 00196449016693 |
NIH Device Record Key | cfd0a6dd-fb96-42b4-b4d0-e0634dd31705 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | A.L.P.S. mvX™ |
Version Model Number | 770102010 |
Catalog Number | 770102010 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
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 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com | |
Phone | +1(866)761-0933 |
preese@tybermed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00196449016693 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-25 |
Device Publish Date | 2023-12-15 |
00196449016853 | 2.0MM FXD ANGLE/VA DBL DRL GDE |
00196449016846 | 1.5MM FXD ANGLE/VA DBL DRL GDE |
00196449016839 | 1.3MM FIXED ANGLE DRILL GUIDE |
00196449016822 | T8 RETENTION DRIVER |
00196449016815 | T6 RETENTION DRIVER |
00196449016808 | T4 RETENTION DRIVER |
00196449016792 | 1.5MM/2.0MM OFFSET PLATE 20H |
00196449016785 | 1.5MM/2.0MM OFFSET PLATE 10H |
00196449016778 | T15 RETENTION DRIVER |
00196449016761 | 2.7MM OVERDRILL |
00196449016754 | ANKLE INSTRUMENT TRAY 2 |
00196449016747 | ANKLE INSTRUMENT TRAY 1 |
00196449016730 | ANKLE OUTER CASE 1 |
00196449016723 | ANKLE OUTER CASE 2 |
00196449016716 | ANKLE SCREW RACK LID |
00196449016709 | ANKLE SCREW RACK |
00196449016693 | ANKLE DISTAL FIB PLT TRAY LID |
00196449016686 | ANKLE DISTAL FIBULA PLATE TRAY |
00196449016679 | MINI FRAG 2.0MM SCREW RACK LID |
00196449016662 | MINI FRAG 2.0MM SCREW RACK |
00196449016655 | MINI FRAG PLATE TRAY 1 |
00196449016648 | MINI FRAG PLATE TRAY 2 |
00196449016631 | MINI FRAG OUTER CASE |
00196449016624 | HAND FAST GUIDE CADDY |
00196449016617 | HAND SCREW RACK LID |
00196449016600 | HAND SCREW RACK |
00196449016594 | HAND PLATE TRAY |
00196449016587 | HAND OUTER CASE |
00196449016570 | SMALL SPIN DOWN FORCEPS |
00196449016518 | 2.0MM OVERDRILL GUIDE |
00196449016501 | 2.4MM OVERDRILL |
00196449016495 | 2.0MM OVERDRILL |
00196449016488 | 1.8MM DRILL SHORT |
00196449016471 | 1.5MM DRILL SHORT |
00196449016457 | 1.0MM DRILL |
00196449016310 | 3.5MM NON-LOCKING SCREW 10MM |
00196449016303 | 2.4MM STRAIGHT TINE PLATE 2H |
00196449016297 | MEDIAL MALLEOLUS HOOK PLATE 5H |
00196449016280 | MEDIAL MALLEOLUS HOOK PLATE 3H |
00196449016273 | POSTLAT TIBIA PLATE 6-5H RT |
00196449016266 | POSTLAT TIBIA PLATE 6-5H LT |
00196449016259 | POSTLAT TIBIA PLATE 6-4H RT |
00196449016242 | POSTLAT TIBIA PLATE 6-4H LT |
00196449016235 | POSTLAT TIBIA PLATE 6-2H RT |
00196449016228 | POSTLAT TIBIA PLATE 6-2H LT |
00196449016211 | POSTLAT TIBIA PLATE 4-5H RT |
00196449016204 | POSTLAT TIBIA PLATE 4-4H RT |
00196449016198 | POSTLAT TIBIA PLATE 4-2H RT |
00196449016181 | POSTLAT TIBIA PLATE 4-5H LT |
00196449016174 | POSTLAT TIBIA PLATE 4-4H LT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
A.L.P.S. MVX 98199222 not registered Live/Pending |
Biomet C.V. 2023-09-27 |