DEVICE: QLRAD (08719326258263)

Device Identifier (DI) Information

QLRAD
105.1018
In Commercial Distribution

QLRAD INTERNATIONAL LTD
08719326258263
GS1

1
534509598 *Terms of Use
RectalPro75, switch valve LL with 100 cc Syringe
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62434 Prostate immobilization balloon catheter
A non-sterile flexible tube with an inflatable balloon at its distal end intended to be inserted into the rectum to facilitate adequate positioning and immobilization of the prostate during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PCT Prostate immobilizer rectal balloon
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180478 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

cf099d9b-1568-4618-afaa-84f5c02922e4
September 22, 2021
1
September 14, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
08719326258287 50 08719326258263 In Commercial Distribution box
08719326258294 2 08719326258287 In Commercial Distribution box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
Yes CLOSE

Customer Contact

[?]
+13054378550
awinkel@qlrad.com
CLOSE