ALTAPORE 1508045
GUDID 00085412654379
Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
Apatech Ltd
Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | 00085412654379 |
| NIH Device Record Key | 854e350d-d011-4a72-a077-24388f0f260a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALTAPORE |
| Version Model Number | 1508045 |
| Catalog Number | 1508045 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
| Total Volume | 8 Milliliter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412654379 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191513
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-19 |
| Device Publish Date | 2019-12-11 |
On-Brand Devices [ALTAPORE]
| 05413760479002 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478999 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478982 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478975 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 05413760478968 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654393 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654386 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654379 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412654362 | Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate |
| 00085412678146 | Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler |
| 00085412630731 | Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler |
Trademark Results [ALTAPORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALTAPORE 87534623 not registered Live/Pending |
Baxter International Inc. 2017-07-19 |
 ALTAPORE 87165257 5633374 Live/Registered |
Baxter International Inc. 2016-09-08 |
 ALTAPORE 86064462 not registered Dead/Abandoned |
Baxter International Inc. 2013-09-13 |
 ALTAPORE 86008035 not registered Dead/Abandoned |
Baxter International Inc. 2013-07-11 |
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