FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M75257032660
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
570-3266
Published
2023-01-18
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75257032660PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
770-962-2425Service@Stradishealthcare.com

Regulatory Flags#

DUNS number
174262477
Device count
1
Premarket exempt
true
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
M752HCT200BP0Stradis Medical, LLC.HCT200BP2017-12-07
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS190580Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-12
10198956255586CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956334373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956381773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956393059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956393103CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956397620CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956400665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956401754CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956426344CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956442429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956450806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956462625CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956464810CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956468443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956475908CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956477773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956479586CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956480155CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956484290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956489363CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956489974CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956492097CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956493506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956494145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956494381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956497733CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956497801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956499096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956499799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09