IsoLoc

Basic Information

• Brand Name: IsoLoc
• Primary DI: 00851546007103
• Version / Model: ISO-100
• Catalog Number: ISO-100
• Company Name: RADIADYNE, L.L.C.
• Labeler DUNS: 005744772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-31
• Public Version: 4
• Public Version Date: 2018-07-27
• Public Version Status: Update
• Public Device Record Key: b88c2eb9-9f20-4cfb-b2ed-001e311b45dd

Device Description

IsoLoc Prostate Immobilization Treatment Balloon Device Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PCT	Prostate Immobilizer Rectal Balloon	Radiology	892.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17781	Rectosphincteric balloon	A hollow rubber structure, expandable with either liquid or air, used in conjunction with a manometer to assess anorectal function (anorectal manometry), typically to evaluate the rectosphincteric reflex upon balloon dilation. The device is typically used in the investigation of lower bowel disorders such as faecal incontinence or Hirschsprung's disease (HD). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851546007107	GS1	Shipper Box	5	In Commercial Distribution
Package	10851546007100	GS1	Shelf Package	20	In Commercial Distribution
Primary	00851546007103	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN130036	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius