Primary Device ID | 00822409006632 |
NIH Device Record Key | 5e4636bf-c629-4cae-82fb-915d87ddd141 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BKS TriMax |
Version Model Number | 165-1405 |
Company DUNS | 876542390 |
Company Name | Ortho Development Corporation |
Device Count | 1 |
DM Exempt | true |
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 | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00822409006632 [Primary] |
JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-12-11 |
Device Publish Date | 2015-08-31 |
00822409031436 | RT Size 7 Femoral CR Nonporous |
00822409031429 | LT Size 7 Femoral CR Nonporous |
00822409031412 | RT Size 6 Femoral CR Nonporous |
00822409031405 | LT Size 6 Femoral CR Nonporous |
00822409031399 | RT Size 5 Narrow Femoral CR Nonporous |
00822409031382 | LT Size 5 Narrow Femoral CR Nonporous |
00822409031375 | RT Size 5 Femoral CR Nonporous |
00822409031368 | LT Size 5 Femoral CR Nonporous |
00822409031351 | RT Size 4 Narrow Femoral CR Nonporous |
00822409031344 | LT Size 4 Narrow Femoral CR Nonporous |
00822409031337 | RT Size 4 Femoral CR Nonporous |
00822409031320 | LT Size 4 Femoral CR Nonporous |
00822409031313 | RT Size 3.5 Femoral CR Nonporous |
00822409031306 | LT Size 3.5 Femoral CR Nonporous |
00822409031290 | RT Size 3 Femoral CR Nonporous |
00822409031283 | LT Size 3 Femoral CR Nonporous |
00822409031276 | RT Size 2.5 Femoral CR Nonporous |
00822409031269 | LT Size 2.5 Femoral CR Nonporous |
00822409031252 | RT Size 2 Femoral CR Nonporous |
00822409031245 | LT Size 2 Femoral CR Nonporous |
00822409031238 | RT Size 1 Femoral CR Nonporous |
00822409031221 | LT Size 1 Femoral CR Nonporous |
00822409006724 | RT Size 7 PS Femoral Nonporous |
00822409006717 | LT Size 7 PS Femoral Nonporous |
00822409006700 | RT Size 6 PS Femoral Nonporous |
00822409006694 | LT Size 6 PS Femoral Nonporous |
00822409006687 | RT Size 5 Narrow PS Femoral Nonporous |
00822409006670 | LT Size 5 Narrow PS Femoral Nonporous |
00822409006663 | RT Size 5 PS Femoral Nonporous |
00822409006656 | LT Size 5 PS Femoral Nonporous |
00822409006649 | RT Size 4 Narrow PS Femoral Nonporous |
00822409006632 | LT Size 4 Narrow PS Femoral Nonporous |
00822409006625 | RT Size 4 PS Femoral Nonporous |
00822409006618 | LT Size 4 PS Femoral Nonporous |
00822409006601 | RT Size 3.5 PS Femoral Nonporous |
00822409006595 | LT Size 3.5 PS Femoral Nonporous |
00822409006588 | RT Size 3 PS Femoral Nonporous |
00822409006571 | LT Size 3 PS Femoral Nonporous |
00822409006564 | RT Size 2.5 PS Femoral Nonporous |
00822409006557 | LT Size 2.5 PS Femoral Nonporous |
00822409006540 | RT Size 2 PS Femoral Nonporous |
00822409006533 | LT Size 2 PS Femoral Nonporous |
00822409006526 | RT Size 1 PS Femoral Nonporous |
00822409006519 | LT Size 1 PS Femoral Nonporous |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BKS TRIMAX 86373511 4805333 Live/Registered |
Ortho Development Corporation 2014-08-21 |