OsteoStrux® 56010100ITL
GUDID 10889981123369
OsteoStrux® Strip, 10cc
SEASPINE ORTHOPEDICS CORPORATION
Bone matrix implant, composite| Primary Device ID | 10889981123369 |
| NIH Device Record Key | b02df1ea-31c4-40e4-9ef8-adf51acd0d7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoStrux® |
| Version Model Number | 56010100ITL |
| Catalog Number | 56010100ITL |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981123369 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063124
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 | 2020-10-27 |
| Device Publish Date | 2020-10-19 |
On-Brand Devices [OsteoStrux®]
| 10889981123376 | OsteoStrux® Strip, 15cc |
| 10889981123369 | OsteoStrux® Strip, 10cc |
| 10889981123352 | OsteoStrux® Putty, 15cc |
| 10889981123345 | OsteoStrux® Putty, 10cc |
| 10889981123338 | OsteoStrux® Putty, 5cc |
| 10889981123321 | OsteoStrux® Putty, 2.5cc |
Trademark Results [OsteoStrux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOSTRUX 77837871 3881271 Live/Registered |
SEASPINE ORTHOPEDICS CORPORATION 2009-09-30 |
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