CURE PRODUCTS

GUDID 10815947021172

Cure Hydrophylic, Male, 16”, Straight Tip, Kit

CONVATEC, PURCHASING DEPARTMENT

Single-administration urethral catheterization kit, single-use
Primary Device ID10815947021172
NIH Device Record Keyb029350d-1c8d-4112-8d88-fcef2a6e0036
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE PRODUCTS
Version Model NumberHM16UK
Company DUNS809784593
Company NameCONVATEC, PURCHASING DEPARTMENT
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815947021175 [Primary]
GS110815947021172 [Package]
Contains: 00815947021175
Package: [30 Units]
In Commercial Distribution
GS120815947021179 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Product Code

OHRCatheter care tray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-08
Device Publish Date2024-03-30

Devices Manufactured by CONVATEC, PURCHASING DEPARTMENT

10768455203946 - ESTEEM2024-09-23 N/A
10768455209481 - ESENTA2024-09-03 ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR
10768455209511 - ESENTA2024-09-03 ESENTA THIN CURVE 3X9CM (1X80PK) NAI
00768455204793 - GENTLECATH2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X30PK US
00768455204823 - GENTLECATH2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X30PK US
00768455204854 - GENTLECATH2024-04-15 GENTLECATH AIR FEM V2.0 CH14 1X30PK US
00768455207145 - GENTLECATH2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X10PK US
00768455207169 - GENTLECATH2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X10PK US

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