RUBY

GUDID 00814548019284

Ruby Standard, 20mm x 60cm

PENUMBRA, INC.

Non-neurovascular embolization coil

• Primary Device ID: 00814548019284
• NIH Device Record Key: dd8537fc-43fe-4e07-a5aa-9429eb432ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RUBY
• Version Model Number: RBY2C2060-B
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814548019284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173614

FDA Product Code

• KRD: Device, Vascular, For Promoting 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: 2021-03-04
• Device Publish Date: 2021-02-24

Devices Manufactured by PENUMBRA, INC.

• 00810169720004 - Indigo System: 2024-10-16 CAT12 100 XTORQ plus Lightning Bolt Aspiration Tubing, no CE
• 00810169720011 - Indigo System: 2024-10-16 CAT12 100 HTORQ plus Lightning Bolt Aspiration Tubing, no CE
• 00810169720028 - Indigo System: 2024-10-16 CAT12 115 XTORQ plus Lightning Bolt Aspiration Tubing, no CE
• 00810169720035 - Indigo System: 2024-10-16 CAT12 115 HTORQ plus Lightning Bolt Aspiration Tubing, no CE
• 00810169721179 - Indigo System: 2024-10-16 CAT6X + Lightning Bolt
• 00810169721186 - Indigo System: 2024-10-16 CAT6X w/Sonic + Lightning Bolt
• M242RBYPODJ150 - POD: 2024-08-23 RBYPODJ15 GS1-00814548016702
• 00815948024267 - Indigo System: 2024-07-26 CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing