Penumbra Coil 400 400PAC60

GUDID 00815948021358

PAC400, 60 cm

PENUMBRA, INC.

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil
Primary Device ID00815948021358
NIH Device Record Keydcfcbd6e-ef46-442d-97bc-f50b0f95b8f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePenumbra Coil 400
Version Model Number400PAC60
Catalog Number400PAC60
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815948021358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-17
Device Publish Date2020-01-09

On-Brand Devices [Penumbra Coil 400]

00814548019697Coil 400 Soft, 9x30
00814548019680Coil 400 Curve, 6x30
00814548019574Coil 400 Curve, 4x10
00814548019567Coil 400 Curve, 4x8
00814548019550Coil 400 Curve, 4x6
00814548019543Coil 400 Curve, 4x4
00814548019536Coil 400 Curve, 3x8
00814548019529Coil 400 Curve, 3x6
00814548019512Coil 400 Curve, 3x5
00814548019505Coil 400 Curve, 3x4
00814548019499Coil 400 Curve, 3x3
00814548019482Coil 400 Curve, 3x2
00814548019475Coil 400 Curve, 2x4
00814548019468Coil 400 Curve, 2x3
00814548019451Coil 400 Curve, 2x2
00814548019444Coil 400 Curve, 2x1
00814548019413Coil 400 Standard, 32x60
00814548019406Coil 400 Standard, 28x60
00814548019383Coil 400 Standard, 24x60
00814548019376Coil 400 Standard, 22x60
00814548019369Coil 400 Standard, 20x60
00814548019345Coil 400 Standard, 18x60
00814548019338Coil 400 Standard, 16x60
00814548019246Coil 400 Soft, 18x45
00814548019222Coil 400 Standard, 15x60
00814548019215Coil 400 Standard, 14x50
00814548019208Coil 400 Standard, 13x48
00814548019192Coil 400 Standard, 12x45
00814548019185Coil 400 Standard, 12x35
00814548019178Coil 400 Standard, 11x45
00814548019161Coil 400 Standard, 11x35
00814548019154Coil 400 Standard, 10x40
00814548019147Coil 400 Standard, 10x30
00814548019130Coil 400 Standard, 10x20
00814548019055Coil 400 Soft, 16x45
00814548019048Coil 400 Soft, 15x45
00814548019031Coil 400 Soft, 14x40
00814548019024Coil 400 Soft, 13x35
00814548019017Coil 400 Soft, 12x35
00814548019000Coil 400 Standard, 9x35
00814548018997Coil 400 Standard, 9x25
00814548018980Coil 400 Standard, 8x30
00814548018973Coil 400 Standard, 8x20
00814548018966Coil 400 Standard, 7x20
00814548018959Coil 400 Standard, 7x15
00814548018942Coil 400 Standard, 7x10
00814548018935Coil 400 Standard, 6x20
00814548018928Coil 400 Standard, 6x15
00814548018911Coil 400 Standard, 6x10
00814548018782Coil 400 Soft, 11x35

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