MEDRAD® PRO-TEKT Endorectal Balloon PROT 50

GUDID 10616258005703

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

BAYER MEDICAL CARE INC.

Radiological pelvis positioner Radiological pelvis positioner

• Primary Device ID: 10616258005703
• NIH Device Record Key: 0adbc13d-f670-4738-8848-a22343cce76b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® PRO-TEKT Endorectal Balloon
• Version Model Number: PROT 50
• Catalog Number: PROT 50
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258005706 [Primary]
GS1	10616258005703 [Package]; Contains: 00616258005706; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• EXX: Probe, Rectal, Non-Powered

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: 2019-03-11
• Device Publish Date: 2016-09-24

Devices Manufactured by BAYER MEDICAL CARE INC.

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• 40616258024309 - Disposable MRI Kit with Check Valve: 2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)
• 40616258024316 - Disposable MRI Kit for 65/115 MR Injector System: 2024-05-14 SOLARIS,KIT,SYR,MRI,65/115ML,MC,CORE (87622460)