Primary Device ID | 07612334207975 |
NIH Device Record Key | 75a2336a-b3ca-49a6-a44a-39bc147a608b |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 09.405.250S |
Catalog Number | 09405250S |
Company DUNS | 486711679 |
Company Name | Synthes GmbH |
Device Count | 1 |
DM Exempt | false |
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(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 | 07612334207975 [Direct Marking] |
GS1 | 10886982300614 [Primary] |
KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-05-02 |
Device Publish Date | 2020-06-08 |
07612334260079 - KINCISE | 2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE |
07612334268587 - KINCISE | 2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID |
07612334268679 - KINCISE | 2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE |
07612334268563 - KINCISE | 2024-11-04 KINCISE™ System Automated Surgical Handpiece V2 |
07612334268570 - KINCISE | 2024-11-04 KINCISE™ System Lithium-ion Battery |
07612334268594 - KINCISE | 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long |
07612334268600 - KINCISE | 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor |
07612334268617 - KINCISE | 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide |