Ostene 1503833
GUDID 55413760467479
Bone Hemostasis Material - 1g
Apatech Ltd
Bone wax, synthetic| Primary Device ID | 55413760467479 |
| NIH Device Record Key | 7f40cdcc-f2b8-4d24-aa6e-79062f86068a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ostene |
| Version Model Number | 1503833 |
| Catalog Number | 1503833 |
| 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
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
| Weight | 1 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413760467474 [Primary] |
| GS1 | 55413760467479 [Package] Contains: 05413760467474 Package: CASE [12 Units] In Commercial Distribution |
FDA Product Code
| MTJ | WAX,BONE |
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 |
On-Brand Devices [Ostene]
| 55413760467479 | Bone Hemostasis Material - 1g |
| 55413760467462 | Bone Hemostasis Material - 2.5g |
| 55413760467455 | Bone Hemostasis Material - 3.5g |
Trademark Results [Ostene]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTENE 78562213 3076194 Live/Registered |
APATECH LIMITED 2005-02-07 |
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