Omnicurve 1033-015-000
GUDID 07613327638226
10G 15MM EXTRA LEVEL
STRYKER CORPORATION
Balloon kyphoplasty kit| Primary Device ID | 07613327638226 |
| NIH Device Record Key | 8ed511c1-8265-45a1-92d3-82c952270141 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnicurve |
| Version Model Number | 1033015000 |
| Catalog Number | 1033-015-000 |
| Company DUNS | 196548481 |
| Company Name | STRYKER 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 | 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
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM | |
| Phone | +1(800)253-3210 |
| INST.STRYKER.CS@STRYKER.COM |
Device Dimensions
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
| Needle Gauge | 11 Gauge |
| Balloon Length | 15 Millimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327638226 [Primary] |
FDA Product Code
| HRX | Arthroscope |
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 | 2024-09-11 |
| Device Publish Date | 2024-09-03 |
On-Brand Devices [Omnicurve]
| 07613327554700 | 11G 20mm Extra Level Kit |
| 07613327554687 | 11G 15mm Extra Level Kit |
| 07613327554663 | 11G 20mm Fracture Kit |
| 07613327554496 | 11G 15mm Fracture Kit |
| 07613327554649 | 11G 30mm Fracture Kit |
| 07613327554724 | 11G 30mm Fracture Kit |
| 07613327638448 | 10G 30MM FRACTURE KIT |
| 07613327638431 | 10G 20MM EXTRA LEVEL |
| 07613327638257 | 10G 30MM EXTRA LEVEL |
| 07613327638240 | 10G 20MM FRACTURE KIT |
| 07613327638233 | 10G 15MM FRACTURE KIT |
| 07613327638226 | 10G 15MM EXTRA LEVEL |
Trademark Results [Omnicurve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNICURVE 88577083 not registered Live/Pending |
Stryker Corporation 2019-08-13 |
 OMNICURVE 73471137 1310948 Dead/Cancelled |
CooperVision, Inc. 1984-03-19 |
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