AccessGUDID - DEVICE: QLRAD (08719326258263)

GUDID

Device Identifier (DI) Information

Brand Name: QLRAD
Version or Model: 105.1018
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QLRAD INTERNATIONAL LTD

Primary DI Number: 08719326258263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534509598 *Terms of Use

Device Description: RectalPro75, switch valve LL with 100 cc Syringe

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
PCT	Prostate immobilizer rectal balloon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180478	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf099d9b-1568-4618-afaa-84f5c02922e4
Public Version Date: September 22, 2021
Public Version Number: 1
DI Record Publish Date: September 14, 2021

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

Phone: +13054378550
Email: awinkel@qlrad.com

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