MEDRAD® PRO-TEKT Endorectal Balloon

FDA UDI

Class I (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name: MEDRAD® PRO-TEKT Endorectal Balloon FDA UDI
Generic Name: Radiological pelvis positioner FDA UDI
Device Name: MEDRAD PRO-TEKT Endorectal Balloon (PRO-TEKT Endorectal Balloon, PROT50) (60729377) FDA UDI
Model / Reference: PROT 50 FDA UDI
Description: MEDRAD PRO-TEKT Endorectal Balloon (PRO-TEKT Endorectal Balloon, PROT50) (60729377) FDA UDI

Identifiers

Catalog Number: PROT 50 FDA UDI
Primary DI / UDI-DI: 00616258005706 FDA UDI
FDA Product Code: EXX FDA UDI
GMDN Term: Radiological pelvis positioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological pelvis positioner

MEDRAD® PRO-TEKT Endorectal Balloon by Bayer Medical Care Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological pelvis positioner.

Positioning Cushion — Medtec LLC · Class II
Qfix® MRI Pelvis System — Qfix · Class II
HipFix® Baseplate — Medtec LLC · Class II
Back/Abdomen SatPad™ — Sat Pad Inc. · Class II
Belly Board MRI — Medtec LLC · Class II
SofTouch™ — Qfix · Class II
SofTouch™ Elite — Qfix · Class II
Prone Thorax Support Cushion — Medtec LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bayer Medical Care Inc.

Sources (1)

FDA UDI 0adbc13d-f670-4738-8848-a22343cce76b 35 fields · synced Jun 9, 2026