IMPEDE-FX Embolization Plug IMP-FX-08

GUDID 10810041650044

IMPEDE-FX Embolization Plug, 8mm

SHAPE MEMORY MEDICAL INC

Vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use

• Primary Device ID: 10810041650044
• NIH Device Record Key: 0f82b926-b14e-40fa-9619-081a68107f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPEDE-FX Embolization Plug
• Version Model Number: IMP-FX-08
• Catalog Number: IMP-FX-08
• 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
GS1	00810041650047 [Primary]
GS1	10810041650044 [Package]; Contains: 00810041650047; Package: [1 Units]; In Commercial Distribution
HIBCC	B054IMPFX081 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182390

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: 2020-04-10
• Device Publish Date: 2020-04-02

On-Brand Devices [IMPEDE-FX Embolization Plug]

• B054IMPFX121: IMPEDE-FX Embolization Plug 12mm
• B054IMPFX081: IMPEDE-FX Embolization Plug 8mm
• B054IMPFX061: IMPEDE-FX Embolization Plug 6mm
• 10810041650051: IMPEDE-FX Embolization Plug, 12mm
• 10810041650044: IMPEDE-FX Embolization Plug, 8mm
• 10810041650037: IMPEDE-FX Embolization Plug, 6mm