KINCISE™ 1010-01-102
GUDID 00845384018568
KINCISE ANTERIOR BROACH ADAPTER
Anspach Effort, The
Surgical power tool adaptor| Primary Device ID | 00845384018568 |
| NIH Device Record Key | e5d7f6fe-21e0-400f-aeca-0facdab0d16e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KINCISE™ |
| Version Model Number | 1010-01-102 |
| Catalog Number | 1010-01-102 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 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 |
| 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 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845384018568 [Primary] |
FDA Product Code
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
[00845384018568]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2020-04-28 |
On-Brand Devices [KINCISE™]
| 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 |
Trademark Results [KINCISE]
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 |
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