Actifuse E-Z-Prep 506005078054
GUDID 05060050780548
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 10ml pack size
Apatech Ltd
Bone matrix implant, synthetic| Primary Device ID | 05060050780548 |
| NIH Device Record Key | 9f7f8e0b-5b9b-4c41-8f77-18e21ad55cbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Actifuse E-Z-Prep |
| Version Model Number | 506005078054 |
| Catalog Number | 506005078054 |
| Company DUNS | 221517829 |
| Company Name | Apatech Ltd |
| 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 |
Customer Support Contacts
Device Dimensions
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060050780548 [Primary] |
FDA Product Code
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-24 |
Devices Manufactured by Apatech Ltd
| 00085412630731 - ALTAPORE | 2022-06-02 Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler |
| 00085412678146 - ALTAPORE | 2021-01-05 Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler |
| 05413760478975 - ALTAPORE | 2020-05-12 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478968 - ALTAPORE | 2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478982 - ALTAPORE | 2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478999 - ALTAPORE | 2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760479002 - ALTAPORE | 2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654362 - ALTAPORE | 2019-12-19 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
Trademark Results [Actifuse E-Z-Prep]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTIFUSE E-Z-PREP 77039232 3580994 Dead/Cancelled |
ApaTech Limited 2006-11-08 |
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