Stradis Medical, LLC.

GUDID M75232080

Foley Insertion Tray

STRADIS MEDICAL, LLC

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use
Primary Device IDM75232080
NIH Device Record Key18257706-0b3f-484b-8610-0ce7f1e6f720
Commercial Distribution StatusIn Commercial Distribution
Brand NameStradis Medical, LLC.
Version Model Number3208
Company DUNS174262477
Company NameSTRADIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM75232080 [Primary]
HIBCCM75232080 [Primary]
HIBCCM75232080 [Primary]
HIBCCM75232080 [Primary]
HIBCCM75232080 [Primary]
HIBCCM75232085 [Package]
Package: outer box [20 Units]
In Commercial Distribution
HIBCCM75232085 [Package]
Package: outer box [20 Units]
In Commercial Distribution
HIBCCM75232085 [Package]
Package: outer box [20 Units]
In Commercial Distribution
HIBCCM75232085 [Package]
Package: outer box [20 Units]
In Commercial Distribution
HIBCCM75232085 [Package]
Package: outer box [20 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-11-06
Device Publish Date2018-03-06

On-Brand Devices [Stradis Medical, LLC.]

M752MSACCESS0PRP Accessories Kit
M752HMACCESS5PRP Accessories Kit
M752GBRM14000PRP Accessories Kit
M752WC1455Wound Pak
M752991017205Mosquito Forceps
M752WC1305Insect Sting Pak
M752UPC1025Bio-Quik Spill Pak
M752IM12605Central Line Kit, Stat
M752525038R105FR Micro-Introducer Kit
M75252503855FR Micro-Introducer Kit
M752750HOSE1Compression Hose Kit
M75268220005Donners and Gloves
M752TMBRF2550Hypodermoclysis Kit
M752SUBMKSQA0Hypodermoclysis Prep Kit
M752RSIV16186N5IV Start Kit
M752O11145IV Start Kit
M752MKSQ011276B0Hypodermoclysis Kit
M752MKSQ011276A5Hypodermoclysis Kit
M752MKSQ011249B5Hypodermoclysis Kit
M752MKSQ011249A5Hypodermoclysis Kit
M752MKSQ011246A5Hypodermoclysis Kit
M752MAG30005Neonatal PICC Tray
M752IVECONO15IV Start ECONO1 Kit W/CHG
M752IV7650IV Start Kit
M752IV7600IV START KIT
M752IV180C5IV Start Kit
M752IV175C0IV Start Kit W/CHLORHEXIDINE
M752IV1750IV Start Kit
M752IV170655IV Start Kit
M752IV162955IV Start Kit
M752ISK95125IV Start Kit
M752ISIVMEC5IV Start Kit
M752ISIV744CP15IV Start Kit
M752ISIV6235IV Start Kit
M752IMSEN102A5IV Start Kit
M752IMSEN101A5PICC/ MIDLINE DRESSING KIT
M752IM12515Central Line Tray
M752IM12355Central Line Tray
M752HCT9925CP0Central Line Dressing Change Kit
M752HCT900ABP0Arterial line Dressing Change Kit - Small Biopatch
M752HCT8874VA0Port Access Tray
M752HCT8136CP0Central Line Dressing Kit
M752HCT8025IV Start Kit
M752HCT801CP0IV Start Kit
M752HCT71820Central Line Dressing Kit
M752HCT6625TC5TUFTS Central line Dressing Change Kit
M752HCT6057CP0Central Line Discontinuation Kit
M752HCT2121CP5IV Start Kit
M752HCT200BP0Dressing Change Kit - Large Biopatch
M752DC850A0PICC/Midline Cath Tray

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.