FDA.reportPublic FDA data

Stradis Medical, LLC.

Primary DI
M752HCT20575
Brand
Stradis Medical, LLC.
Company
STRADIS MEDICAL, LLC
Model
HCT2057
Device description
Basic Chemo Spill Kit
Published
2017-12-07
Public version status
Update
Distribution status
Not 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
PWTChemotherapy Spill Clean-Up Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWTChemotherapy Spill Clean-Up KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752HCT20575PackageHIBCC30Not in Commercial Distribution
M752HCT20570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cytotoxic material spill kitA set of devices used to clean up spillage of cytotoxic material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. 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
174262477
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31
M7521697700Stradis Medical, LLC.1697702018-03-22
M752ACC25001Stradis Medical, LLC.ACC-25002018-01-29
M752ACC2500N1Stradis Medical, LLC.ACC-2500N2018-04-13
M752ACC25501Stradis Medical, LLC.ACC-25502018-01-29
M752DC1790911Stradis Medical, LLC.DC-17909-12018-05-22
M752DC51601Stradis Medical, LLC.DC-51602018-05-22
M752HCT6625TC0Stradis Medical, LLC.HCT6625TC2017-12-12
M752IM12350Stradis Medical, LLC.IM12352017-12-15
M752IM12510Stradis Medical, LLC.IM12512017-12-15
M752IM12600Stradis Medical, LLC.IM12602019-04-17
M752IMSEN101A0Stradis Medical, LLC.IM-SEN-101A2017-12-14
M752MAG30001Stradis Medical, LLC.MAG-30002018-05-30
M752ACC2550N1Stradis Medical, LLC.ACC-2550N2018-03-27
M752DC850A0Stradis Medical, LLC.DC-850A2018-04-23
M752HCT200BP0Stradis Medical, LLC.HCT200BP2017-12-07
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12

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Primary DI, Brand, Company table
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00827989007956Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-02-12
00827989007949Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-02-09
00850015884375easycareSynchronis Medical, LLCPWT2026-01-07
00850015884382easycareSynchronis Medical, LLCPWT2026-01-07
10827989004075Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2024-05-03
10827989004082Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2024-05-03
10809160408452Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-09-08
20809160408459Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-09-08
10809160402962Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-06-16
20809160402969Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-06-16
10809160398944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-05-04
20809160398941Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-05-04
10809160398609Health Care TechnologyMEDICAL ACTION INDUSTRIES INC.PWT2023-04-25
20809160398606Health Care TechnologyMEDICAL ACTION INDUSTRIES INC.PWT2023-04-25
M752HCT20570Stradis Medical, LLC.STRADIS MEDICAL, LLCPWT2017-12-07
10884389534892MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PWT2016-11-07