Primary Device ID | 00810022402399 |
NIH Device Record Key | a21c2049-9ad2-4449-b1ca-ffce6c6ecf2b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LinkBio Instrument |
Version Model Number | 87-1909/01 |
Company DUNS | 827608774 |
Company Name | Link Bio Corp |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810022402399 [Primary] |
HTW | Bit, Drill |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
[00810022402399]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-21 |
Device Publish Date | 2022-06-10 |
00810022402351 | LinkBio Instruments Tray: TrabecuLink Tibial Cones |
00810022401590 | LinkBio Instrument Tray (Mega C): Mega C General Instruments |
00810022401583 | LinkBio Instrument Trays (Mega C): Mega C Assembly Tools |
00810022401576 | LinkBio Instrument Tray (Mega C): Mega C Proximal Femur General Instruments |
00810022401569 | LinkBio Instruments Tray (Mega C): Mega C Stem Segments/Push Thru/Intercalary Trials |
00810022401552 | LinkBio Instrument Tray (Mega C): Mega C SL Tibia Prep Instruments |
00810022401545 | LinkBio Instrument Tray (Mega C): Mega C General Tibia Stem Trials and Extraction Tools |
00810022401538 | LinkBio Instrument Tray (Mega C): Mega C SL Femoral, Tibia Trials & Augments |
00810022401521 | LinkBio Instrument Trays (Mega C): Mega C Classic Femoral & Tibia Augments and Trials |
00810022401514 | LinkBio Instrument Tray (Mega C): Mega C Classic Femoral & Tibia Prep Inst. With Trials |
00810022401507 | LinkBio Instrument Trays (Mega C): Mega C 160mm Reamers and 160mm Femoral Stem Trials |
00810022401491 | LinkBio Instrument Trays (Mega C): Mega C 130mm Reamers and 130mm Femoral Stem Trials |
00810022401484 | LinkBio Instrument Tray (Mega C): Mega C 100mm Reamers and 100mm Femoral Stem Trials |
00810022402344 | Guide Rod, Tibial Cone, D 16/180 L |
00810022402337 | Guide Rod, Tibial Cone, D 14/180 L |
00810022402320 | Guide Rod, Tibial Cone, D 12/180 L |
00810022402313 | Guide Rod, Tibial Cone, D 10/180 L |
00810022402306 | Guide Rod, Tibial Cone, D 8/180 L |
00810022402290 | Broach, Tibial Cone, Starter Full |
00810022402283 | Broach, Tibial Cone, Starter Half |
00810022402276 | Guide Rod, Tibial Cone, D 18/120 L |
00810022402269 | Guide Rod, Tibial Cone, D 16/120 L |
00810022402252 | Guide Rod, Tibial Cone, D 14/120 L |
00810022402245 | Guide Rod, Tibial Cone, D 12/120 L |
00810022402238 | Guide Rod, Tibial Cone, D 10/120 L |
00810022402207 | Starter Reamer, Tibial Cone |
00810022402146 | Broach, Tibial Cone, L Full |
00810022402139 | Broach, Tibial Cone, M Full |
00810022402122 | Broach, Tibial Cone, S Full |
00810022402115 | Broach, Tibial Cone, XS Full |
00810022402108 | Broach, Tibial Cone, L Half |
00810022402092 | Broach, Tibial Cone, M Half |
00810022402085 | Broach, Tibial Cone, S Half |
00810022402078 | Broach, Tibial Cone, XS Half |
00810022400005 | SL Valgus Block with Drill Holes |
00810022402573 | Starter Reamer, Cone |
00810022401897 | Endo W/M Tibial Trial, Modular Post - Large |
00810022401880 | Endo W/M Tibial Trial, Modular Post - Medium |
00810022401873 | Endo W/M Tibial Trial, Modular Post - Small |
00810022401866 | Endo W Femoral Trial Adaptor - Modular Post |
00810022401859 | Endo M/W Femoral Trial, Modular Post - Large, Right |
00810022401842 | Endo M/W Femoral Trial, Modular Post - Large, Left |
00810022401835 | Endo M/W Femoral Trial, Modular Post - Medium, Right |
00810022401828 | Endo M/W Femoral Trial, Modular Post - Medium, Left |
00810022401811 | Endo M/W Femoral Trial, Modular Post - Small, Right |
00810022401804 | Endo M/W Femoral Trial, Modular Post - Small, Left |
00810022403013 | Impactor Plate, Tibial Cone Large |
00810022403006 | Impactor Plate, Tibial Cone Medium |
00810022402993 | Impactor Plate, Tibial Cone Small |
00810022402986 | Impactor Plate, Tibial Cone Extra Small |