FDA.report

GDC-10

Primary DI
04546540689283
Brand
GDC-10
Company
Stryker Corporation
Model
M003344304SR40
Catalog number
344304-SR4
Device description
2D 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

Related Records

Contact Domains

Product Codes

CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540689283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540689283045465406892834546540689283

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

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