AVAflex 1025011000
GUDID 07613327374612
AVAflex Curved Needle Kit
STRYKER CORPORATION
Orthopaedic cement injection cannula| Primary Device ID | 07613327374612 |
| NIH Device Record Key | 38cad0c4-73d6-4d35-913e-6ee411d1546d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVAflex |
| Version Model Number | 1025011000 |
| Catalog Number | 1025011000 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| 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 | true |
| 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
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327374612 [Primary] |
FDA Product Code
| OAR | Injector, vertebroplasty (does not contain cement) |
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 | 2018-06-04 |
| Device Publish Date | 2018-05-04 |
On-Brand Devices [AVAflex]
| 07613327374629 | AVAflex Curved Needle |
| 07613327374612 | AVAflex Curved Needle Kit |
| 07613327374605 | 11 gauge 15mm AVAflex Vertebral Balloon System |
| 07613327374599 | 10 gauge 30mm AVAflex Vertebral Balloon System |
| 07613327374582 | 11 gauge 20mm AVAflex Vertebral Balloon System |
| 07613327374575 | 10 gauge 20mm AVAflex Vertebral Balloon System |
| 07613327374568 | 10 gauge 15mm AVAflex Vertebral Balloon System |
| 07613327374551 | 11 gauge 30mm AVAflex Vertebral Balloon System |
Trademark Results [AVAflex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVAFLEX 78943423 3332802 Live/Registered |
STRYKER CORPORATION 2006-08-02 |
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