LP Coil System

GUDID 00815948021938

Packing Coil LP, 30cm

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 ID00815948021938
NIH Device Record Keycbe52953-4dc4-49c8-9524-2c181b701eb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLP Coil System
Version Model NumberRBYPCLP30
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 Numbertrue
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
GS100815948021938 [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 Date2020-01-29
Device Publish Date2020-01-21

On-Brand Devices [LP Coil System]

00815948021976Ruby Coil LP, 1mm x 1cm
00815948022232Packing Coil LP, 20cm
00815948022225Packing Coil LP, 12cm
00815948022218Packing Coil LP, 8cm
00815948022201Packing Coil LP, 5cm
00815948022195Ruby Coil LP, 8mm x 50cm
00815948022188Ruby Coil LP, 8mm x 40cm
00815948022171Ruby Coil LP, 8mm x 30cm
00815948022164Ruby Coil LP, 8mm x 20cm
00815948022157Ruby Coil LP, 7mm x 30cm
00815948022140Ruby Coil LP, 7mm x 20cm
00815948022133Ruby Coil LP, 6mm x 20cm
00815948022126Ruby Coil LP, 6mm x 15cm
00815948022119Ruby Coil LP, 5mm x 20cm
00815948022102Ruby Coil LP, 5mm x 15cm
00815948022096Ruby Coil LP, 4mm x 20cm
00815948022089Ruby Coil LP, 4mm x 12cm
00815948022065Ruby Coil LP, 4mm x 8cm
00815948022058Ruby Coil LP, 3mm x 12cm
00815948022041Ruby Coil LP, 3mm x 8cm
00815948022034Ruby Coil LP, 3mm x 6cm
00815948022027Ruby Coil LP, 2mm x 8cm
00815948022010Ruby Coil LP, 2mm x 6cm
00815948022003Ruby Coil LP, 2mm x 1cm
00815948021990Ruby Coil LP, 1mm x 4cm
00815948021983Ruby Coil LP, 1mm x 3cm
00815948021969LP Detachment Handle
00815948021952Packing Coil LP, 60cm
00815948021945Packing Coil LP, 45cm
00815948021938Packing Coil LP, 30cm
00815948021921Packing Coil LP, 15cm
00815948021914Packing Coil LP, 10cm
00815948021907Packing Coil LP, 6cm
00815948021891Packing Coil LP, 3cm
00815948021884Ruby Coil LP, 8 mm x 60 cm
00815948021877Ruby Coil LP, 7 mm x 40 cm
00815948021860Ruby Coil LP, 6 mm x 30 cm
00815948021853Ruby Coil LP, 6 mm x 10 cm
00815948021846Ruby Coil LP, 5 mm x 30 cm
00815948021839Ruby Coil LP, 5 mm x 10 cm
00815948021822Ruby Coil LP, 4 mm x 30 cm
00815948021815Ruby Coil LP, 4 mm x 15 cm
00815948021808Ruby Coil LP, 4 mm x 6 cm
00815948021792Ruby Coil LP, 3 mm x 15 cm
00815948021785Ruby Coil LP, 3 mm x 10 cm
00815948021778Ruby Coil LP, 3 mm x 4 cm
00815948021761Ruby Coil LP, 2 mm x 10 cm
00815948021754Ruby Coil LP, 2 mm x 4 cm
00815948021747Ruby Coil LP, 2 mm x 2 cm
00815948021730Ruby Coil LP, 1 mm x 5 cm

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