FDA.reportPublic FDA data

MATRIX2

Primary DI
04546540691187
Brand
MATRIX2
Company
Stryker Corporation
Model
M003490408SR0
Catalog number
490408-SR
Device description
360 Soft SR Detachable Coil
Published
2015-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540691187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540691187045465406911874546540691187

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA sterile, non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
false
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303714262Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714279Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714286Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714293Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714309Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714316Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714323Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714330Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714347Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714354Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714361Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714378Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714385Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714392Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714408Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714415Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714422Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714439Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714446Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714453Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714460Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714477Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714484Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00810169722039swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722046swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722053swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722060swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722077swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722084swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722091swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26