ImmobiLoc IL-100

GUDID 20851546007022

ImmobiLoc Prostate Immobilization Treatment Balloon Device Kit

RADIADYNE, L.L.C.

Rectosphincteric balloon

• Primary Device ID: 20851546007022
• NIH Device Record Key: 7f70b8af-4964-41b1-9fe7-40aeae34ea19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmobiLoc
• Version Model Number: IL-100
• Catalog Number: IL-100
• Company DUNS: 005744772
• Company Name: RADIADYNE, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com
• Phone: 281-759-9600
• Email: leahroe@radiadyne.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851546007028 [Primary]
GS1	10851546007025 [Package]; Contains: 00851546007028; Package: Shelf Carton [20 Units]; In Commercial Distribution
GS1	20851546007022 [Package]; Contains: 10851546007025; Package: Shipper Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN130036

FDA Product Code

• PCT: Prostate Immobilizer Rectal Balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [ImmobiLoc]

• 20851546007053: ImmobiLoc Gas Release Prostate Immobilization Treatment Balloon Device Kit
• 20851546007046: ImmobiLoc Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit W/60ml
• 20851546007039: ImmobiLoc Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit
• 20851546007022: ImmobiLoc Prostate Immobilization Treatment Balloon Device Kit
• 20851546007015: ImmobiLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit