POD

GUDID 00814548017679

RBYPODJ60

PENUMBRA, INC.

Embolization implant kit

• Primary Device ID: 00814548017679
• NIH Device Record Key: a2420fb1-8af8-4c6d-b347-0e830141a03a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POD
• Version Model Number: RBYPODJ60-A
• 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: 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	00814548017679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170852

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-27

On-Brand Devices [POD]

• 00814548019673: POD, 14x60
• 00814548019666: POD, 12x60
• 00814548019659: POD, 10x60
• 00814548019642: POD, 9x60
• 00814548019635: POD, 8x60
• 00814548019628: POD, 7x60
• 00814548019611: POD, 6x50
• 00814548019604: POD, 5x30
• 00814548019598: POD, 4x30
• 00814548019581: POD, 3x20
• 00814548017679: RBYPODJ60
• 00814548017662: RBYPODJ45
• 00814548017655: RBYPODJ30
• 00814548017648: RBYPODJ15
• 00814548017631: RBYPODJ5
• 00815948020351: POD Neuro, 6x50
• 00815948020344: POD Neuro, 5x30
• 00815948020337: POD Neuro, 4x30
• 00815948020320: POD Neuro, 3x20
• M424RBYPODJ450: RBYPODJ45
• M242RBYPODJ150: RBYPODJ15 GS1-00814548016702