FDA.report

STRADIS HEALTHCARE

Primary DI
M75257026860
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
570-2686
Published
2022-03-10
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

Related Records

Contact Domains

Product Codes

CodeName
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications

CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M75257026860PrimaryHIBCC0

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM
770-962-2425SALES@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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956345971CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
50198956309416CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
50198956063646CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
B098R404ROJFB1Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
50197106799572CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
50197106781249CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
50197106784455CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
50197106704903CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
50197106602421CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106615193CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
00191072215246ACSAMERICAN CONTRACT SYSTEMS, INC.HIO2024-01-12
50197106448692CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
10849233013763Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
25060259071304AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
05060259071317AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
50197106421404CARDINAL HEALTHCardinal Health 200, LLCHIO2023-09-08
50197106234790CARDINAL HEALTHCardinal Health 200, LLCHIO2023-05-23
50197106089000CARDINAL HEALTHCardinal Health 200, LLCHIO2023-02-24
10849233008820Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2022-11-14
50195594770226CARDINAL HEALTHCardinal Health 200, LLCHIO2022-10-27
M75257030591Stradis STRADIS MEDICAL, LLCHIO2022-08-09
20886333220797Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
20886333220803Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
20886333224306Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
50195594688415CARDINAL HEALTHCardinal Health 200, LLCHIO2022-07-07
50195594673848CARDINAL HEALTHCardinal Health 200, LLCHIO2022-05-13
H65857030591Henry ScheinHENRY SCHEIN, INC.HIO2022-04-26
M75257014560STRADIS HEALTHCARESTRADIS MEDICAL, LLCHIO2022-03-07
50888439858370CARDINAL HEALTHCardinal Health 200, LLCHIO2022-01-07
50195594409034CARDINAL HEALTHCardinal Health 200, LLCHIO2021-11-30