Indigo

GUDID 00815948024281

Indigo CATD Kit

PENUMBRA, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00815948024281
• NIH Device Record Key: 07e84217-cbac-4fd4-be06-0d224066f296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo
• Version Model Number: CATD-U
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00815948024281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142870

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

[00815948024281]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [Indigo]

• 00814548017624: CATD
• 00814548017600: SEPD
• 00815948020481: Indigo CATD Kit
• 00815948022423: Indigo CATD Kit
• 00815948022348: Aspiration Catheter D Kit
• 00815948022331: Aspiration Catheter D Kit, CE
• 00814548019765: Ind Engine Canister Assembly, CE
• 00815948024281: Indigo CATD Kit