FDA.reportPublic FDA data

Penumbra Coil 400

Primary DI
M4244004C02040
Brand
Penumbra Coil 400
Company
PENUMBRA, INC.
Model
4004C0204
Device description
PC400 Cplx Std, 2x4
Published
2016-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103305000PENUMBRA EMBOLIZATION COIL SYSTEMPenumbra, Inc.2011-01-26HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M4244004C02040PrimaryHIBCC0
00814548013718SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548013718008145480137188145480137180814548013718

GMDN Terms#

Term, Definition table
TermDefinition
Embolization implant kitA collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814548014258Smart Coil400SMTSTD13452016-07-30
00814548014265Smart Coil400SMTSTD13602016-07-30
00814548014272Smart Coil400SMTSTD14452016-07-30
00814548014289Smart Coil400SMTSTD14602016-07-30
00814548014296Smart Coil400SMTSTD15452016-07-30
00814548014302Smart Coil400SMTSTD15602016-07-30
00814548014319Smart Coil400SMTSTD16452016-07-30
00814548014326Smart Coil400SMTSTD16602016-07-30
00814548014333Smart Coil400SMTSTD18452016-07-30
00814548014340Smart Coil400SMTSTD18602016-07-30
00814548014357Smart Coil400SMTSTD09202016-07-30
00814548014364Smart Coil400SMTSTD09302016-07-30
00814548014395Smart Coil400SMTSTD10302016-07-30
00814548014401Smart Coil400SMTSTD10452016-07-30
00814548014418Smart Coil400SMTSTD11452016-07-30
00814548014425Smart Coil400SMTSTD11602016-07-30
00814548014432Smart Coil400SMTSTD12452016-07-30
00814548014449Smart Coil400SMTSTD12602016-07-30
00814548014463Smart Coil400SMTSTD11352016-07-30
00814548014470Smart Coil400SMTSTD12352016-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540688897GDC-10Stryker CorporationHCG2015-09-21
04546540688910GDC-10Stryker CorporationHCG2015-09-21
04546540688934GDC-10Stryker CorporationHCG2015-09-21
04546540688958GDC-10Stryker CorporationHCG2015-09-21
04546540689054GDC-10Stryker CorporationHCG2015-09-21
04546540689061GDC-10Stryker CorporationHCG2015-09-21
04546540689078GDC-10Stryker CorporationHCG2015-09-21
04546540689085GDC-10Stryker CorporationHCG2015-09-21
04546540689092GDC-10Stryker CorporationHCG2015-09-21
04546540689108GDC-10Stryker CorporationHCG2015-09-21
04546540689115GDC-10Stryker CorporationHCG2015-09-21
04546540689122GDC-10Stryker CorporationHCG2015-09-21
04546540689139GDC-10Stryker CorporationHCG2015-09-21
04546540689146GDC-10Stryker CorporationHCG2015-09-21
04546540689153GDC-10Stryker CorporationHCG2015-09-21
04546540689160GDC-10Stryker CorporationHCG2015-09-21
04546540689177GDC-10Stryker CorporationHCG2015-09-21
04546540689184GDC-10Stryker CorporationHCG2015-09-21
04546540689191GDC-10Stryker CorporationHCG2015-09-21
04546540689207GDC-10Stryker CorporationHCG2015-09-21
04546540689214GDC-10Stryker CorporationHCG2015-09-21
04546540689221GDC-10Stryker CorporationHCG2015-09-21
04546540689238GDC-10Stryker CorporationHCG2015-09-21
04546540689245GDC-10Stryker CorporationHCG2015-09-21
04546540689252GDC-10Stryker CorporationHCG2015-09-21
04546540689269GDC-10Stryker CorporationHCG2015-09-21
04546540689276GDC-10Stryker CorporationHCG2015-09-21
04546540689283GDC-10Stryker CorporationHCG2015-09-21
04546540689290GDC-10Stryker CorporationHCG2015-09-21
04546540689306GDC-10Stryker CorporationHCG2015-09-21