| Primary Device ID | 10603295125969 |
| NIH Device Record Key | 606699b0-8038-43a6-871d-ad9fb5143d41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMK |
| Version Model Number | 2490-98-000 |
| Catalog Number | 249098000 |
| Company DUNS | 080506581 |
| Company Name | DEPUY ORTHOPAEDICS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295125969 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
[10603295125969]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-05-13 |
| Device Publish Date | 2018-09-24 |
| 10603295039624 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 9.5mm x 38mm |
| 10603295039617 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 8.5mm x 34mm |
| 10603295039600 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 10mm x 40mm |
| 10603295039594 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 7.5mm x 30mm |
| 10603295039389 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 10mm x 40mm |
| 10603295039372 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 9.5mm x 38mm |
| 10603295039365 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 9mm x 36mm |
| 10603295039358 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 8.5mm x 34mm |
| 10603295039341 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 7.5mm x 30mm |
| 10603295039334 | AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 7.5mm x 26mm |
| 10603295125969 | AMK FIXATION PIN .125in x 3in |