Omnicurve 1033-115-000
GUDID 07613327554687
11G 15mm Extra Level Kit
STRYKER CORPORATION
Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit| Primary Device ID | 07613327554687 |
| NIH Device Record Key | edd12493-a07f-4041-aa3e-f76df9c551d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnicurve |
| Version Model Number | 1033-115-000 |
| Catalog Number | 1033-115-000 |
| 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 | 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
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327554687 [Primary] |
FDA Product Code
| NDN | CEMENT, BONE, VERTEBROPLASTY |
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 | 2022-04-20 |
| Device Publish Date | 2022-04-12 |
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 |
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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