QLRAD

GUDID 08719326258287

RectalPro75, switch valve LL with 100 cc Syringe

QLRAD INTERNATIONAL LTD

Prostate immobilization balloon catheter

• Primary Device ID: 08719326258287
• NIH Device Record Key: cf099d9b-1568-4618-afaa-84f5c02922e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QLRAD
• Version Model Number: 105.1018
• Company DUNS: 534509598
• Company Name: QLRAD INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com
• Phone: +13054378550
• Email: awinkel@qlrad.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719326258263 [Primary]
GS1	08719326258287 [Package]; Contains: 08719326258263; Package: box [50 Units]; In Commercial Distribution
GS1	08719326258294 [Package]; Package: box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180478

FDA Product Code

• PCT: Prostate immobilizer rectal balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-22
• Device Publish Date: 2021-09-14

On-Brand Devices [QLRAD]

• 08719326258218: RectalPro75
• 08719326258287: RectalPro75, switch valve LL with 100 cc Syringe
• 08719326258256: RectalPro75
• 08720892233035: Inframammary Fold Breast Wedge Large
• 08720892233004: Inframammary Fold Breast Wedge Small