Stradis Medical, LLC

GUDID M752HCT35485

12CC SYRINGE KIT

STRADIS MEDICAL LLC

General-purpose syringe, single-use
Primary Device IDM752HCT35485
NIH Device Record Key00a9ab6f-c5b9-4d27-a993-925b38bddc58
Commercial Distribution StatusIn Commercial Distribution
Brand NameStradis Medical, LLC
Version Model NumberHCT3548
Company DUNS043537671
Company NameSTRADIS MEDICAL LLC
Device Count20
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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM752HCT35480 [Unit of Use]
HIBCCM752HCT35481 [Primary]
HIBCCM752HCT35482 [Package]
Contains: M752HCT35481
Package: Inner bag [5 Units]
In Commercial Distribution
HIBCCM752HCT35485 [Package]
Contains: M752HCT35482
Package: outer box [5 Units]
In Commercial Distribution

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [Stradis Medical, LLC]

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M752IM12655Dressing Change Kit with SorbaView
M752TM882315Port Access Tray
M752SXPOUCH5Surgery Prep & Recovery Kit
M752IM12646Hazardous Drug Spill Kit
M752TM882316Port Access Tray
M752IM22015IV START KIT W/CHLORAPREP, GEN
M752COTA81385Explant Kit
M752COTA81365Implant Kit
M752HCT3548512CC SYRINGE KIT

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