| Primary Device ID | M6848400SD061 |
| NIH Device Record Key | f6ccb89f-fc26-4579-bc76-28af24f11133 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lineage |
| Version Model Number | 8400SD06 |
| Catalog Number | 8400SD06 |
| Company DUNS | 079118736 |
| Company Name | Microport Orthopedics Inc. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192629042537 [Primary] |
| HIBCC | M6848400SD061 [Previous] |
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
[M6848400SD061]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-20 |
| Device Publish Date | 2025-06-12 |
| 26012805 | COCR FEMORAL HEAD 28MM SLT TAPER +10.5MM NECK |
| 26012804 | COCR FEMORAL HEAD 28MM SLT TAPER +7MM NECK |
| 26012803 | COCR FEMORAL HEAD 28MM SLT TAPER +3.5MM NECK |
| 26012802 | COCR FEMORAL HEAD 28MM SLT TAPER +0MM NECK |
| 26012801 | COCR FEMORAL HEAD 28MM SLT TAPER -3.5MM NECK |
| 26010010 | COCR FEMORAL HEAD 32MM SLT TAPER X-LONG NECK |
| 26010009 | COCR FEMORAL HEAD 32MM SLT TAPER LONG NECK |
| 26010008 | COCR FEMORAL HEAD 32MM SLT TAPER MEDIUM NECK |
| 26010007 | COCR FEMORAL HEAD 32MM SLT TAPER SHORT NECK |
| 26010003 | COCR FEMORAL HEAD 22.25MM SLT TAPER LONG NECK |
| 26010002 | COCR FEMORAL HEAD 22.25MM TAPER MEDIUM NECK |
| 26010001 | COCR FEMORAL HEAD 22.25MM TAPER X-LONG NECK |
| 26000015 | CERAMIC FEMORAL HEAD 36mm SLT TAPER LONG NECK |
| 26000014 | CERAMIC FEMORAL HEAD 36mm SLT TAPER MEDIUM NECK |
| 26000013 | CERAMIC FEMORAL HEAD 36mm SLT TAPER SHORT NECK |
| 26000012 | CERAMIC FEMORAL HEAD 36mm SLT TAPER LONG NECK |
| 26000011 | CERAMIC FEMORAL HEAD 36mm SLT TAPER MEDIUM NECK |
| 26000010 | CERAMIC FEMORAL HEAD 36mm SLT TAPER SHORT NECK |
| 26000009 | CERAMIC FEMORAL HEAD 32mm SLT TAPER LONG NECK |
| 26000008 | CERAMIC FEMORAL HEAD 32mm SLT TAPER MEDIUM NECK |
| 26000007 | CERAMIC FEMORAL HEAD 32mm SLT TAPER SHORT NECK |
| 26000006 | CERAMIC FEMORAL HEAD 28mm SLT TAPER LONG NECK |
| 26000005 | CERAMIC FEMORAL HEAD 28mm SLT TAPER MEDIUM NECK |
| 26000004 | CERAMIC FEMORAL HEAD 28mm SLT TAPER SHORT NECK |
| M6848400SD031 | UNIVERSAL JOINT 3.5MM HEX DRIVER SHFT W/STRYKER FIT |
| M6848400SD061 | HEX DRIVER SHAFT W/STRYKR STRAIGHT SOLID 3.5MM |
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