FDA.report

TARGET

Primary DI
04546540697974
Brand
TARGET
Company
Stryker Corporation
Model
M0035421030
Catalog number
542103
Device description
360 Nano 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

Related Records

Contact Domains

Product Codes

CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications

CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540697974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540697974045465406979744546540697974

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, dark place.

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
00763000936594Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936600Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936617Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936624Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936631Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936648Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936655Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936662Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936679Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936686Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936693Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936709Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936716Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936723Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936730Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936747Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936754Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936761Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936778Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936785Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936792Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936808Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936815Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936822Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936839Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936846Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936853Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936860Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936877Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936884Concerto Versa™MEDTRONIC, INC.KRD2026-02-27