iVAS 0808-115-000
GUDID 37613327142717
11 gauge 15mm iVAS Elite Single Balloon Kit
STRYKER CORPORATION
Balloon kyphoplasty kit| Primary Device ID | 37613327142717 |
| NIH Device Record Key | 662b04a3-5fa0-466c-b996-e72d359f94b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iVAS |
| Version Model Number | 808115000 |
| Catalog Number | 0808-115-000 |
| 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 | 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 | |
| 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
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 11 Gauge |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
| Storage 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327142716 [Primary] |
| GS1 | 37613327142717 [Package] Contains: 07613327142716 Package: pack [3 Units] In Commercial Distribution |
FDA Product Code
| NDN | CEMENT, BONE, VERTEBROPLASTY |
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 | 2019-07-05 |
| Device Publish Date | 2018-03-08 |
On-Brand Devices [iVAS]
| 37613327389815 | BONE BIOPSY KIT |
| 07613327374483 | Inflatable Vertebral Augmentation System |
| 07613327374476 | Inflatable Vertebral Augmentation System |
| 07613327374469 | Inflatable Vertebral Augmentation System |
| 37613327374453 | ACCESS CANNULA |
| 07613327358346 | 8 gauge 15mm iVAS Elite Fracture Kit |
| 07613327358339 | 11 gauge 15mm iVAS Elite Fracture Kit |
| 07613327358322 | 8 gauge 20mm iVAS Elite Fracture Kit |
| 07613327358315 | 11 gauge 10mm iVAS Elite Fracture Kit |
| 07613327358308 | 10 gauge 10mm iVAS Elite Fracture Kit |
| 07613327358278 | 10 gauge 15mm iVAS Elite Fracture Kit |
| 37613327297783 | Bevel Stylet |
| 37613327297776 | Bevel Stylet |
| 37613327142793 | 8 gauge 20mm iVAS Elite Single Kit |
| 37613327142786 | 10 gauge 15mm iVAS Elite Single Balloon Kit |
| 37613327142779 | 8 gauge 15mm iVAS Elite Single Balloon Kit |
| 37613327142762 | 11 gauge 15mm iVAS Elite Balloon Catheter |
| 37613327142755 | 10 gauge 20mm iVAS Elite Balloon Catheter |
| 37613327142748 | 11 gauge 10mm iVAS Elite Balloon Catheter |
| 37613327142731 | 10 gauge 15mm iVAS Elite Balloon Catheter |
| 37613327142724 | 10 gauge 10mm iVAS Elite Balloon Catheter |
| 37613327142717 | 11 gauge 15mm iVAS Elite Single Balloon Kit |
| 37613327142700 | 11 gauge 10mm iVAS Elite Single Kit |
| 37613327142694 | 10 gauge 20mm iVAS Elite Single Kit |
| 37613327142687 | 10 gauge 10mm iVAS Elite Single Kit |
| 37613252594209 | Bone Biopsy Kit |
| 37613252506004 | Balloon Catheter |
| 37613252505991 | Access Cannula |
| 37613252505984 | Inflatable Vertebral Augmentation System |
| 37613252505977 | Ballon Catheter |
| 37613252505960 | Inflatable Vertabral Augmentation System |
| 37613252467909 | Inflatable Vertebral Augmentation System |
| 37613252293171 | Balloon Catheter |
| 37613252293164 | Infaltable Vertebral Augmentation System |
| 37613252276280 | Inflatable Vertebral Augmentation System |
| 37613252276273 | Inflatable Vertebral Augmentation System |
| 37613252202623 | Bone Biopsy Kit |
| 37613252170519 | Bone Biopsy Kit |
| 37613252170502 | Bevel Stylet |
| 37613252170496 | Access Cannula |
| 37613252163627 | Balloon Catheter |
| 37613252163610 | Inflatable Vertebral Augmentation System |
| 37613252158784 | Access Cannula |
| 37613252052020 | Balloon Catheter |
| 37613252029831 | Inflatable Vertebral Augmentation System |
| 07613327358292 | 10 gauge 10mm iVAS Elite Single Kit |
Trademark Results [iVAS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IVAS 88048739 not registered Live/Pending |
Solera Holdings, Inc. 2018-07-23 |
 IVAS 85363346 4230926 Live/Registered |
I.V.A.S. Industria Vernici S.p.A. 2011-07-05 |
 IVAS 77729288 3854552 Live/Registered |
STRYKER CORPORATION 2009-05-05 |
 IVAS 77402737 not registered Dead/Abandoned |
University of Medicine and Dentistry ofNew Jersey 2008-02-21 |
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