FDA.reportPublic FDA data

Stradis Medical, LLC

Primary DI
M752DC560A0
Brand
Stradis Medical, LLC
Company
STRADIS MEDICAL LLC
Model
DC-560A
Device description
Dressing Change Tray
Published
2021-05-03
Public version status
Update
Distribution status
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
M752DC560A5PackageHIBCC30In Commercial Distribution
M752DC560A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicated, sterileA collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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