IsoLoc ISO-60

GUDID 00851546007092

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit

RADIADYNE, L.L.C.

Rectosphincteric balloon

• Primary Device ID: 00851546007092
• NIH Device Record Key: 6c503fc6-240b-47ca-9cec-23f971c05628
• Commercial Distribution Discontinuation: 2018-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IsoLoc
• Version Model Number: ISO-60
• Catalog Number: ISO-60
• 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: 2817599600
• Email: sabrinamartilla@radiadyne.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851546007091 [Primary]
GS1	00851546007092 [Package]; Contains: 00851546007091; Package: Shelf Package [20 Units]; Discontinued: 2018-01-31; Not 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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-31

On-Brand Devices [IsoLoc]

• 20851546007213: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
• 20851546007107: IsoLoc Prostate Immobilization Treatment Balloon Device Kit
• 00851546007092: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
• 20851546007091: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit