MEDRAD® PRO-TEKT Endorectal Balloon

Basic Information

• Brand Name: MEDRAD® PRO-TEKT Endorectal Balloon
• Primary DI: 00616258005706
• Version / Model: PROT 50
• Catalog Number: PROT 50
• Company Name: BAYER MEDICAL CARE INC.
• Labeler DUNS: 058716649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: 0adbc13d-f670-4738-8848-a22343cce76b

Device Description

MEDRAD PRO-TEKT Endorectal Balloon (PRO-TEKT Endorectal Balloon, PROT50) (60729377)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40901	Radiological pelvis positioner	A device intended to facilitate adequate positioning and immobilization of the patient's pelvic area during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10616258005703	GS1		50	In Commercial Distribution	9999-12-31
Primary	00616258005706	GS1

Customer Contacts

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