Surpass Elite FDSE40020
GUDID 07613327582796
Flow Diverter System
Stryker Corporation
Bare-metal intracranial vascular stent| Primary Device ID | 07613327582796 |
| NIH Device Record Key | 0849f07f-e65e-45ff-9e72-e7a5928a2e4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surpass Elite |
| Version Model Number | FDSE40020 |
| Catalog Number | FDSE40020 |
| Company DUNS | 042405446 |
| Company Name | Stryker Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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
Device Dimensions
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327582796 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P170024
FDA Product Code
| OUT | Intracranial aneurysm flow diverter |
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 | 2024-07-24 |
| Device Publish Date | 2024-07-16 |
On-Brand Devices [Surpass Elite]
| 07613327582598 | Flow Diverter System |
| 07613327587869 | Flow Diverter System |
| 07613327583250 | Flow Diverter System |
| 07613327582796 | Flow Diverter System |
| 07613327582857 | Flow Diverter System |
| 07613327582802 | Flow Diverter System |
| 07613327582789 | Flow Diverter System |
| 07613327582765 | Flow Diverter System |
| 07613327582758 | Flow Diverter System |
| 07613327582741 | Flow Diverter System |
| 07613327582734 | Flow Diverter System |
| 07613327582710 | Flow Diverter System |
| 07613327582697 | Flow Diverter System |
| 07613327582680 | Flow Diverter System |
| 07613327582673 | Flow Diverter System |
| 07613327582666 | Flow Diverter System |
| 07613327582659 | Flow Diverter System |
| 07613327582642 | Flow Diverter System |
| 07613327582635 | Flow Diverter System |
| 07613327582628 | Flow Diverter System |
| 07613327582611 | Flow Diverter System |
| 07613327582604 | Flow Diverter System |
| 07613327582581 | Flow Diverter System |
| 07613327587852 | Flow Diverter System |
| 07613327587845 | Flow Diverter System |
| 07613327587791 | Flow Diverter System |
| 07613327583434 | Flow Diverter System |
| 07613327583304 | Flow Diverter System |
| 07613327583281 | Flow Diverter System |
| 07613327583274 | Flow Diverter System |
| 07613327583267 | Flow Diverter System |
| 07613327583243 | Flow Diverter System |
| 07613327583236 | Flow Diverter System |
| 07613327583229 | Flow Diverter System |
| 07613327583212 | Flow Diverter System |
| 07613327583205 | Flow Diverter System |
| 07613327583199 | Flow Diverter System |
| 07613327583182 | Flow Diverter System |
| 07613327583175 | Flow Diverter System |
| 07613327583168 | Flow Diverter System |
| 07613327583151 | Flow Diverter System |
| 07613327583144 | Flow Diverter System |
| 07613327583137 | Flow Diverter System |
| 07613327583120 | Flow Diverter System |
| 07613327583113 | Flow Diverter System |
| 07613327583106 | Flow Diverter System |
| 07613327583090 | Flow Diverter System |
| 07613327583083 | Flow Diverter System |
| 07613327583038 | Flow Diverter System |
| 07613327583021 | Flow Diverter System |
Trademark Results [Surpass Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURPASS ELITE 97369362 not registered Live/Pending |
Stryker Corporation 2022-04-19 |
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