FDA.reportPublic FDA data

Stradis Medical, LLC.

Primary DI
M752HCT59750KA5
Brand
Stradis Medical, LLC.
Company
STRADIS MEDICAL LLC
Model
HCT5975OK-A
Device description
Oncology Stop Kit
Published
2020-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWSChemotherapy Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWSChemotherapy Administration KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752HCT59750KA5PackageHIBCC50In Commercial Distribution
M752HCT59750KA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-424-8520cs@stradishealthcare.com

Regulatory Flags#

DUNS number
043537671
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M752CPD20000Stradis Medical, LLCCPD-20002020-04-14
M752ACC26001Stradis Medical, LLC.ACC-26002019-09-24
M752DC1790920Stradis Medical, LLC.DC-17909-22020-06-10
M752HCT200GD20Stradis Medical, LLC.HCT200GD-22020-07-16
M752HCT6186CP10Stradis Medical, LLCHCT6186CP-12020-07-02
M752HCT8874VA20Stradis Medical, LLC.HCT8874VA-22019-10-08
M752HCT900AGD10Stradis Medical, LLC.HCT900AGD-12020-07-23
M752TM85161Stradis Medical, LLC.TM85162019-09-06
M752TM85170Stradis Medical, LLC.TM.85172021-03-05
M752TM882310Stradis Medical, LLCTM8823-12019-06-21
M752TM882311Stradis Medical, LLCTM8823-12019-07-22
M752TMCLK10Stradis Medical, LLCTMCLK-12019-12-23
M752TMCLK20Stradis Medical, LLCTMCLK-22021-04-13
M752HCT900CHX0ARTERIAL LINE DRESSING CHANGE KITHCT900CHX2022-01-10
M752HCT6625CTA0Stradis Medical, LLC.HCT6625TC-A2020-07-13
M752HCT100GD20Stradis Medical, LLCHCT100GD-22020-07-16
M752TN170313069C0Stradis Medical, LLCTN1703-13069C2020-06-16
M752TSBRF6640Stradis Medical, LLCTSBRF-6642020-10-26
M752TSBRF6630Stradis Medical, LLCTSBRF-6632020-10-26
M752HCT8249CP3A0Stradis Medical, LLC.HCT8249CP-3A2020-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M752HCT5975OKB0Stradis Medical, LLC.STRADIS MEDICAL LLCPWS2021-04-09
M752HCT59750KA0Stradis Medical, LLC.STRADIS MEDICAL LLCPWS2020-07-02