INZONE 451009-5
GUDID 04546540697950
DETACHMENT SYSTEM
Stryker Corporation
Vascular implant detacher, single-use, sterile| Primary Device ID | 04546540697950 |
| NIH Device Record Key | fc125587-8e06-477a-a8d7-bd04d4d368d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INZONE |
| Version Model Number | M00345100950 |
| Catalog Number | 451009-5 |
| Company DUNS | 042405446 |
| 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
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. |
| 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. |
| 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 | 04546540697950 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120816
FDA Product Code
| KRD | Device, Vascular, for Promoting Embolization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [INZONE]
| 04546540697950 | DETACHMENT SYSTEM |
| 04546540675811 | DETACHMENT SYSTEM |
Trademark Results [INZONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INZONE 97326258 not registered Live/Pending |
Samuel Lavone Wolfe Jr 2022-03-23 |
 INZONE 88683533 not registered Live/Pending |
Weatherford Technology Holdings, LLC 2019-11-07 |
 INZONE 88675190 not registered Live/Pending |
Nuance Hearing Ltd. 2019-10-31 |
 INZONE 87627673 not registered Dead/Abandoned |
Weatherford Technology Holdings, LLC 2017-09-29 |
 INZONE 86421366 4890323 Live/Registered |
InZoneMobile LLC 2014-10-11 |
 INZONE 86421363 4890322 Live/Registered |
InZoneMobile LLC 2014-10-11 |
 INZONE 85432527 not registered Dead/Abandoned |
E&B Giftware LLC 2011-09-27 |
 INZONE 79328666 not registered Live/Pending |
Sony of Canada Ltd. 2021-11-17 |
 INZONE 77545095 3911514 Live/Registered |
STRYKER EUROPEAN HOLDINGS I, LLC 2008-08-12 |
INZONE 77545095 3911514 Live/Registered |
STRYKER NV OPERATIONS LIMITED 2008-08-12 |
 INZONE 76421225 not registered Dead/Abandoned |
INDEVEX HOLDINGS LTD. 2002-06-17 |
 INZONE 75566879 2342684 Dead/Cancelled |
FineLine Properties, Inc. 1998-10-08 |
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