| Primary Device ID | 00822409071630 | 
| NIH Device Record Key | 3520f5c2-c696-41c6-9d61-729232b51113 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | n/a | 
| Version Model Number | T2 | 
| 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 | false | 
| 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 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| 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 | 
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| Phone | +1(801)553-9991 | 
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| 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 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
| customerservice@odev.com | |
| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
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| Phone | +1(801)553-9991 | 
| customerservice@odev.com | |
| Phone | +1(801)553-9991 | 
| customerservice@odev.com | 
| Length | 50 Millimeter | 
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| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00822409071630 [Primary] | 
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
[00822409071630]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-08-18 | 
| Device Publish Date | 2020-08-10 | 
| 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 |