IMPEDE Embolization Plug IMP-10

GUDID B054IMP101

IMPEDE Embolization Plug 10mm

SHAPE MEMORY MEDICAL INC

Vascular occluder, single-use

• Primary Device ID: B054IMP101
• NIH Device Record Key: 2a852979-29f2-47a2-8d02-c3f00e972a8b
• Commercial Distribution Discontinuation: 2021-03-12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPEDE Embolization Plug
• Version Model Number: IMP-10
• Catalog Number: IMP-10
• Company DUNS: 025984823
• Company Name: SHAPE MEMORY MEDICAL 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B054IMP101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181051

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-03
• Device Publish Date: 2019-10-31

On-Brand Devices [IMPEDE Embolization Plug]

• B054IMP101: IMPEDE Embolization Plug 10mm
• B054IMP071: IMPEDE Embolization Plug 7mm
• B054IMP051: IMPEDE Embolization Plug 5mm
• 10810041650020: IMPEDE Embolization Plug, 10mm
• 10810041650013: IMPEDE Embolization Plug, 7mm
• 10810041650006: IMPEDE Embolization Plug, 5mm