RUBY Coil RBY2C0435

GUDID 00814548018614

Ruby Standard, 4x35

PENUMBRA, INC.

Embolization implant kit
Primary Device ID00814548018614
NIH Device Record Key99f9acc3-d16f-48ec-b94e-e229b3c1250e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRUBY Coil
Version Model NumberRBY2C0435-B
Catalog NumberRBY2C0435
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814548018614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-15

On-Brand Devices [RUBY Coil]

00814548019437Ruby Standard, 40x60
00814548019420Ruby Standard, 36x60
00814548019321Ruby Standard, 32x60
00814548019314Ruby Standard, 28x60
00814548019291Ruby Standard, 24x60
00814548019260Ruby Standard, 18x60
00814548019253Ruby Standard, 16x60
00814548019123Ruby Soft, 20x60
00814548019116Ruby Standard, 14x60
00814548019109Ruby Standard, 14x40
00814548019093Ruby Standard, 12x60
00814548019086Ruby Standard, 12x40
00814548019079Ruby Standard, 10x60
00814548019062Ruby Standard, 10x35
00814548018904Ruby Soft, 16x50
00814548018898Ruby Soft, 12x60
00814548018881Ruby Soft, 12x40
00814548018874Ruby Standard, 9x30
00814548018867Ruby Standard, 8x40
00814548018850Ruby Standard, 8x25
00814548018843Ruby Standard, 7x40
00814548018836Ruby Standard, 7x25
00814548018829Ruby Standard, 6x40
00814548018812Ruby Standard, 6x30
00814548018805Ruby Standard, 6x20
00814548018799Ruby Standard, 6x12
00814548018669Ruby Soft, 10x35
00814548018652Ruby Standard, 5x35
00814548018645Ruby Standard, 5x30
00814548018638Ruby Standard, 5x20
00814548018621Ruby Standard, 5x12
00814548018614Ruby Standard, 4x35
00814548018607Ruby Standard, 4x30
00814548018591Ruby Standard, 4x20
00814548018584Ruby Standard, 4x15
00814548018577Ruby Standard, 4x10
00814548018560Ruby Standard, 3x20
00814548018553Ruby Standard, 3x12
00814548018546Ruby Standard, 3x5
00814548018393Ruby Soft, 8x60
00814548018386Ruby Soft, 8x35
00814548018379Ruby Soft, 6x60
00814548018362Ruby Soft, 6x30
00814548018355Ruby Soft, 6x20
00814548018348Ruby Soft, 4x15
00814548018331Ruby Soft, 4x6
00814548018324Ruby Soft, 3x15
00814548018317Ruby Soft, 3x5
00814548018300Ruby Soft, 2x12
00814548018294Ruby Soft, 2x10

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