FDA.report

STRADIS

Primary DI
M7528204041
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
820-404
Device description
STERILE SEPARATE-GAUZE 4X4
Published
2017-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MGPDressing, Wound And Burn, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
MGPDressing, Wound And Burn, OcclusiveUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M7528204041PrimaryHIBCC0

GMDN Terms

TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Device Sizes

TypeValueUnit
Length4Inch

Sterilization Methods

Method

Contacts

PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags

DUNS number
174262477
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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M7529992814665Stradis Medical, LLC.9992814662018-10-02
M7529992814705Stradis Medical, LLC.9992814702018-12-13
M7529992814715Stradis Medical, LLC.9992814712018-12-13
M7529992814725Stradis Medical, LLC.9992814722018-11-21
M7529992814735Stradis Medical, LLC.9992814732018-11-21
M7529992814745Stradis Medical, LLC.9992814742018-11-16
M7529992814755Stradis Medical, LLC.9992814752018-12-17
M7529992814765Stradis Medical, LLC.9992814762018-09-27
M7529992815585Stradis Medical, LLC.9992815582018-12-13
M752682PREG1Stradis Medical, LLC682-PREG2017-08-08
M75257032000STRADIS HEALTHCARE570-32002022-12-19
M75257032180STRADIS HEALTHCARE570-32182022-12-19
M75257032310STRADIS HEALTHCARE570-32312022-12-19
M75257032380STRADIS HEALTHCARE570-32382022-12-20
M7521000125Stradis Medical, LLC.1000122018-10-08
M7521000161Stradis Medical, LLC.1000162018-10-08
M7521000175Stradis Medical, LLC1000172018-10-08

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