FDA.report

STRADIS HEALTHCARE

Primary DI
M7526871050
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
687-105
Device description
CUSTOM SURGICAL KIT OPHTHALMIC PACK
Published
2022-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PXCPersonal Protection Kit

Product Code Classifications

CodeDeviceSpecialtyClass
PXCPersonal Protection KitGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M7526871050PrimaryHIBCC0

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags

DUNS number
174262477
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M7529992814655Stradis Medical, LLC.9992814652018-12-13
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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