FDA.reportPublic FDA data

GDC-10

Primary DI
04546540689719
Brand
GDC-10
Company
Stryker Corporation
Model
M003346820SR0
Catalog number
346820-SR
Device description
360 Standard SR Detachable Coil
Published
2015-09-21
Public version status
Update
Distribution status
Not 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
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540689719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540689719045465406897194546540689719

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA 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.

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
04546540466242NA04072500000407-250-0002016-09-23
04546540500229NA04072810000407-281-0002016-09-23
04546540531827NA04072510000407-251-0002016-09-23
04546540144164NA02100100000210-010-0002015-09-24
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-10-01
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01