Primary Device ID | 00845384018575 |
NIH Device Record Key | eec70e29-2132-436e-9513-231569759e31 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KINCISE™ |
Version Model Number | 1011-01-101 |
Catalog Number | 1011-01-101 |
Company DUNS | 079116867 |
Company Name | Anspach Effort, The |
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 | false |
Serial Number | true |
Manufacturing Date | false |
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 |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 59.5 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00845384018575 [Primary] |
GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
[00845384018575]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-06 |
Device Publish Date | 2020-04-28 |
00845384018629 | KINCISE FEM HEAD IMPACTOR, REPLACE CAP |
00845384018612 | KINCISE FEMORAL HEAD IMPACTOR |
00845384018582 | KINCISE BULLET TIP STEM INSERTER |
00845384018575 | KINCISE PINNACLE SHELL/LINER IMPACTOR |
00845384018568 | KINCISE ANTERIOR BROACH ADAPTER |
00845384018551 | KINCISE POSTERIOR BROACH ADAPTER |
00845384018544 | KINCISE 4-PORT BATTERY CHARGER |
00845384018537 | KINCISE RECHARGEABLE LI-ION BATTERY |
00845384018520 | KINCISE AUTOMATED SURGICAL IMPACTOR |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() KINCISE 90105877 not registered Live/Pending |
Depuy Synthes, Inc. 2020-08-11 |
![]() KINCISE 88032292 not registered Live/Pending |
Depuy Synthes, Inc. 2018-07-10 |