FDA.reportPublic FDA data

Stradis Medical, LLC.

Primary DI
M752HCT200BP0
Brand
Stradis Medical, LLC.
Company
STRADIS MEDICAL, LLC
Model
HCT200BP
Device description
Dressing Change Kit - Large Biopatch
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCYWound Dressing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752HCT200BP5PackageHIBCC30In Commercial Distribution
M752HCT200BP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. 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
Kit
true
Lot or batch
true
Expiration date on label
true

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
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12
M752HCT71820Stradis Medical, LLC.HCT71822017-12-12

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