FDA.reportPublic FDA data

Penumbra Coil 400

Primary DI
M4244004J40
Brand
Penumbra Coil 400
Company
PENUMBRA, INC.
Model
4004J4
Device description
PC400 J Sft, 4cm
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
M4244004J40PrimaryHIBCC0
00814548011288SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548011288008145480112888145480112880814548011288

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
00810169723586swiftMATCH Coil, Extra Soft400SWXSFT510-A400SWXSFT5102026-10-01
00810169723593swiftMATCH Coil, Extra Soft400SWXSFT615-A400SWXSFT6152026-10-01
00810169723609swiftMATCH Coil, Soft400SWSFT610-A400SWSFT6102026-10-01
00810169723616swiftMATCH Coil, Soft400SWSFT615-A400SWSFT6152026-10-01
00810169723623swiftMATCH Coil, Soft400SWSFT715-A400SWSFT7152026-10-01
00810169723630swiftMATCH Coil, Soft400SWSFT820-A400SWSFT8202026-10-01
00810169723647swiftMATCH Coil, Standard400SWSTD408-A400SWSTD4082026-10-01
00810169723654swiftMATCH Coil, Standard400SWSTD510-A400SWSTD5102026-10-01
00810169723661swiftMATCH Coil, Standard400SWSTD515-A400SWSTD5152026-10-01
00810169723678swiftMATCH Coil, Standard400SWSTD615-A400SWSTD6152026-10-01
00810169723685swiftMATCH Coil, Standard400SWSTD620-A400SWSTD6202026-10-01
00810169723692swiftMATCH Coil, Standard400SWSTD725-A400SWSTD7252026-10-01
00810169723708swiftMATCH Coil, Standard400SWSTD830-A400SWSTD8302026-10-01
00810169724217Ruby XL Coil SystemRBYPODXL0310-ARBYPODXL03102026-10-01
00810169724224Ruby XL Coil SystemRBYPODXL0320-ARBYPODXL03202026-10-01
00810169724231Ruby XL Coil SystemRBYPODXL0720-ARBYPODXL07202026-10-01
00810169724248Ruby XL Coil SystemRBYPODXL0755-ARBYPODXL07552026-10-01
00810169724255Ruby XL Coil SystemRBYPODXL0830-ARBYPODXL08302026-10-01
00810169724262Ruby XL Coil SystemRBYPODXL0930-ARBYPODXL09302026-10-01
00810169724279Ruby XL Coil SystemRBYPODXL0955-ARBYPODXL0955-A2026-10-01

Other Devices Sharing Product Codes#

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