LP Coil System

GUDID 00815948021952

Packing Coil LP, 60cm

PENUMBRA, INC.

Neurovascular embolization coil

• Primary Device ID: 00815948021952
• NIH Device Record Key: 7ca404be-ccc3-4ce1-b64f-eac3707d5f9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LP Coil System
• Version Model Number: RBYPCLP60
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948021952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192955

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-29
• Device Publish Date: 2020-01-21

On-Brand Devices [LP Coil System]

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