FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M7526821349R11
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
682-1349R1
Device description
CUSTOM SURGICAL KIT ENDOVENOUS PACK
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7526821349R11PackageHIBCC5In Commercial Distribution
M7526821349R10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
No natural rubber latex
true
Sterilization required before use
false

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
00884450493182Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-14
00884450493199Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-14
10809160527009HalyardAVID MEDICAL, INC.OEZ2026-07-13
00884450450949Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-11
00884450108765Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-10
00884450487334Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-10
00884450486436Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
00884450488812Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
10198956119437CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956345942CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956360358CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956365056CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956418424CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956421479CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956439870CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956462182CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956480834CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956483408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956485662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956488861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956490871CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956491502CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492332CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956496415CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956502420CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503915CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504011CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504325CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09