FDA.reportPublic FDA data

InZone IST

Primary DI
07613327635096
Brand
InZone IST
Company
Stryker Corporation
Model
IST345100960
Catalog number
IST345100960
Device description
Detachment System
Published
2026-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251832000InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular2025-10-17HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327635096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327635096076133276350967613327635096

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, electronic, single-useA noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, dark place.

Contacts#

Phone, Email table
PhoneEmail
+1(855)916-3876NVCustomerService@stryker.com

Regulatory Flags#

DUNS number
042405446
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29
04546540722812WingspanM003WS0300200M003WS03002002015-05-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
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00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
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00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06