MTG 32212

GUDID 50850025153688

MTG EZ Advancer Soft Pre-Lubricated 12fr male

HR PHARMACEUTICALS INC.

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 50850025153688
• NIH Device Record Key: 792b7e8c-2f4e-4c6d-ba49-15e7b592abfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTG
• Version Model Number: 32212
• Catalog Number: 32212
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025153683 [Primary]
GS1	50850025153688 [Package]; Contains: 00850025153683; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080878

FDA Product Code

• KOD: CATHETER, UROLOGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [MTG]

• 50850025153725: MTG Cath-Lean Pre-Lubricated 12fr
• 50850025153718: MTG EZ Advancer MiniPak 16fr Kit
• 50850025153701: MTG Cath-Lean Pre-Lubricated 14fr
• 50850025153695: MTG Kiddie-Kath 8fr Kit
• 50850025153688: MTG EZ Advancer Soft Pre-Lubricated 12fr male
• 50850025153671: MTG EZ Advancer Pre-Lubricated 16 fr male
• 50850025153664: MTG Jiffy Cath Closed systems 14fr pre-lubricated urinary catheter with PvP
• 50850025153657: MTG EZ Advancer Pre-Lubricated 14fr male
• 50850025153640: MTG EZ Advancer Pre-Lubricated 12fr male
• 50850025153633: MTG EZ Advancer MiniPak 10fr
• 50850025153626: MTG Kiddie-Kath 8fr
• 50850025153619: 14fr Coude, No Kit
• 50850025153602: 12fr Coude, No Kit
• 50850025153596: 14fr Coude Kit - SOFT
• 50850025153589: 16fr Coude Kit
• 50850025153572: 14fr Coude Kit
• 50850025153565: 12fr Coude Kit
• 50850025153558: 16fr 16" Kit
• 50850025153541: 14fr 16" Kit
• 50850025153534: 12fr 16" Kit
• 50850025153527: Jiffy Mini-Pak 16 FR
• 50850025153510: Jiffy Mini-Pak 14 FR
• 50850025153503: Jiffy Mini-Pak 12 FR
• 50850025153275: EZ-Advancer 14FR with PVP
• 50850025153268: Cath-Lean 14FR
• 50850025153251: EZ-Advancer Mini 14FR
• 50850025153244: EZ-Advancer 14FR SOFT
• 50850025153237: EZ-Advancer 14FR
• 50850025153220: EZ-Advancer Mini 12FR
• 50850025153213: EZ-Advancer 12FR
• 50850025153206: EZ-Advancer 10FR
• 50850025153190: EZ-Advancer Mini 10FR
• 50850025153183: Kiddie Kath 8FR
• 50850045818222: EZ advancer Mini Pack 14 fr non kit
• 50850045818192: MTG EZ-Gripper®
• 50850045818185: MTG EZ-Gripper®
• 50850045818178: MTG EZ-Gripper®
• 50850045818161: MTG EZ-Gripper®
• 50850045818154: MTG EZ-Gripper®
• 50850045818147: MTG EZ-Gripper®
• 50850045818130: MTG EZ-Gripper®
• 50850045818123: MTG EZ-Gripper®
• 50850045818116: MTG EZ-Gripper®
• 50850045818109: MTG EZ-Gripper®
• 50850045818093: Cath Lean 12fr, without kit
• 50850045818055: MTG Jiffy Cath ™ Coude 16fr
• 50850045818048: MTG Jiffy Cath ™ Coude 12fr
• 50850045818024: MTG Jiffy Cath ™16 fr
• 50850045818017: MTG Jiffy Cath ™ 14fr
• 50850045818000: MTG Jiffy Cath ™12fr