QLRAD

GUDID 08719326258287

RectalPro75, switch valve LL with 100 cc Syringe

QLRAD INTERNATIONAL LTD

Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter 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