KINCISE™ 1003-00-101
GUDID 00845384018544
KINCISE 4-PORT BATTERY CHARGER
Anspach Effort, The
Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger| Primary Device ID | 00845384018544 |
| NIH Device Record Key | 59073c42-4e2a-4057-9176-fd8cf5c100a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KINCISE™ |
| Version Model Number | 1003-00-101 |
| Catalog Number | 1003-00-101 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845384018544 [Primary] |
FDA Product Code
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
Moist Heat or Steam Sterilization
[00845384018544]
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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