Primary Device ID | 00822409084197 |
NIH Device Record Key | 5c62e11f-9c19-4d58-a4c3-74c75b26f9fd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | 238-3200P |
Company DUNS | 876542390 |
Company Name | Ortho Development Corporation |
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 | false |
OTC Over-The-Counter | false |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Outer Diameter | 32 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00822409084197 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
[00822409084197]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-05 |
Device Publish Date | 2024-05-28 |
00822409045082 | Straight Anterior Broach Handle |
00822409044474 | CR Insert Trials Size 6 |
00822409044467 | CR Insert Trials Size 6 |
00822409044450 | CR Insert Trials Size 6 |
00822409044443 | CR Insert Trials Size 6 |
00822409044436 | CR Insert Trials Size 5 |
00822409044429 | CR Insert Trials Size 5 |
00822409044412 | CR Insert Trials Size 5 |
00822409044405 | CR Insert Trials Size 5 |
00822409044399 | CR Insert Trials Size 4 |
00822409044382 | CR Insert Trials Size 4 |
00822409044375 | CR Insert Trials Size 4 |
00822409044368 | CR Insert Trials Size 4 |
00822409044351 | CR Insert Trials Size 3 |
00822409044344 | CR Insert Trials Size 3 |
00822409044337 | CR Insert Trials Size 3 |
00822409044320 | CR Insert Trials Size 3 |
00822409044313 | CR Insert Trials Size 2 |
00822409044306 | CR Insert Trials Size 2 |
00822409044290 | CR Insert Trials Size 2 |
00822409044283 | CR Insert Trials Size 2 |
00822409044276 | Wingnut Patella Reaming Handle |
00822409046546 | Single Offset Broach Handle |
00822409046539 | 2mm Tibial Recut Block |
00822409071630 | Threaded Collarless Pin 50mm |
00822409071623 | Threaded Collared Pin 50mm |
00822409071272 | TibTrialSpacer Lg Height 30mm |
00822409071265 | TibTrialSpacer Lg Height 25mm |
00822409071258 | TibTrialSpacer Lg Height 20mm |
00822409071241 | TibTrialSpacer Lg Height18mm |
00822409071234 | TibTrialSpacer Lg Height16mm |
00822409071227 | TibTrialSpacer Lg Height14mm |
00822409071210 | TibTrialSpacer Lg Height12mm |
00822409071203 | TibTrialSpacer Lg Height10mm |
00822409071197 | TibTrialSpacer Med Height30mm |
00822409071180 | TibTrialSpacer Med Height25mm |
00822409071173 | TibTrialSpacer Med Height20mm |
00822409071166 | TibTrialSpacer Med Height18mm |
00822409071159 | TibTrialSpacer Med Height16mm |
00822409071142 | TibTrialSpacer Med Height14mm |
00822409071135 | TibTrialSpacer Med Height12mm |
00822409071128 | TibTrialSpacer Med Height10mm |
00822409071111 | TibTrialSpacerSmall Height30mm |
00822409071104 | TibTrialSpacerSmall Height25mm |
00822409071098 | TibTrialSpacerSmall Height20mm |
00822409071081 | TibTrialSpacerSmall Height18mm |
00822409071074 | TibTrialSpacerSmall Height16mm |
00822409071067 | TibTrialSpacerSmall Height14mm |
00822409071050 | TibTrialSpacerSmall Height12mm |
00822409071043 | TibTrialSpacerSmall Height10mm |