MTG 20116

GUDID 50850045818024

MTG Jiffy Cath ™16 fr

HR PHARMACEUTICALS INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID50850045818024
NIH Device Record Key1ed42330-d4f9-473a-b152-f85a382952dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG
Version Model Number20116
Catalog Number20116
Company DUNS828918164
Company NameHR PHARMACEUTICALS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com
Phone+1(717)252-1110
Emailsbenser@hrpharma.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850045818029 [Primary]
GS150850045818024 [Package]
Contains: 00850045818029
Package: Case [100 Units]
In Commercial Distribution

FDA Product Code

KODCATHETER, UROLOGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


[50850045818024]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-14
Device Publish Date2023-04-06

On-Brand Devices [MTG]

50850025153725MTG Cath-Lean Pre-Lubricated 12fr
50850025153718MTG EZ Advancer MiniPak 16fr Kit
50850025153701MTG Cath-Lean Pre-Lubricated 14fr
50850025153695MTG Kiddie-Kath 8fr Kit
50850025153688MTG EZ Advancer Soft Pre-Lubricated 12fr male
50850025153671MTG EZ Advancer Pre-Lubricated 16 fr male
50850025153664MTG Jiffy Cath Closed systems 14fr pre-lubricated urinary catheter with PvP
50850025153657MTG EZ Advancer Pre-Lubricated 14fr male
50850025153640MTG EZ Advancer Pre-Lubricated 12fr male
50850025153633MTG EZ Advancer MiniPak 10fr
50850025153626MTG Kiddie-Kath 8fr
5085002515361914fr Coude, No Kit
5085002515360212fr Coude, No Kit
5085002515359614fr Coude Kit - SOFT
5085002515358916fr Coude Kit
5085002515357214fr Coude Kit
5085002515356512fr Coude Kit
5085002515355816fr 16" Kit
5085002515354114fr 16" Kit
5085002515353412fr 16" Kit
50850025153527Jiffy Mini-Pak 16 FR
50850025153510Jiffy Mini-Pak 14 FR
50850025153503Jiffy Mini-Pak 12 FR
50850025153275EZ-Advancer 14FR with PVP
50850025153268Cath-Lean 14FR
50850025153251EZ-Advancer Mini 14FR
50850025153244EZ-Advancer 14FR SOFT
50850025153237EZ-Advancer 14FR
50850025153220EZ-Advancer Mini 12FR
50850025153213EZ-Advancer 12FR
50850025153206EZ-Advancer 10FR
50850025153190EZ-Advancer Mini 10FR
50850025153183Kiddie Kath 8FR
50850045818222EZ advancer Mini Pack 14 fr non kit
50850045818192MTG EZ-Gripper®
50850045818185MTG EZ-Gripper®
50850045818178MTG EZ-Gripper®
50850045818161MTG EZ-Gripper®
50850045818154MTG EZ-Gripper®
50850045818147MTG EZ-Gripper®
50850045818130MTG EZ-Gripper®
50850045818123MTG EZ-Gripper®
50850045818116MTG EZ-Gripper®
50850045818109MTG EZ-Gripper®
50850045818093Cath Lean 12fr, without kit
50850045818055MTG Jiffy Cath ™ Coude 16fr
50850045818048MTG Jiffy Cath ™ Coude 12fr
50850045818024MTG Jiffy Cath ™16 fr
50850045818017MTG Jiffy Cath ™ 14fr
50850045818000MTG Jiffy Cath ™12fr

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.