FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M752KPX3209A0
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
KPX3209A
Published
2022-03-03
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
PKELaparoscopic Cholecystectomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKELaparoscopic Cholecystectomy KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752KPX3209A1PackageHIBCC6In Commercial Distribution
M752KPX3209A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 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
false
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00304040166888Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
H65857031361Henry ScheinHENRY SCHEIN, INC.PKE2022-08-10
M75257029180Stradis Medical, LLC.STRADIS MEDICAL, LLCPKE2022-04-25
M7526902620STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-21
M75257014820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
M7526902530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
50195594582843CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
M75257019510STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-03
00191072144430ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2021-08-25
00191072120991ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2021-01-05
00191072087409ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2020-09-24
50888439831274CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
50888439782385CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439795866CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439793596CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
50888439678695CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
50888439766927CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
50888439771549CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02
50888439629574CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-26
50888439763544CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-25
50888439721063CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-19
50888439745489CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-19
50888439741238CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-17
50888439729373CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-12
50888439719008CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-10
50888439658642CARDINAL HEALTHCardinal Health 200, LLCPKE2019-12-23
00191072072566ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2019-08-15
50888439520826CARDINAL HEALTHCardinal Health 200, LLCPKE2019-07-08
50888439511480CARDINAL HEALTHCardinal Health 200, LLCPKE2019-07-05
50888439515518CARDINAL HEALTHCardinal Health 200, LLCPKE2019-06-21