FDA.reportPublic FDA data

Stradis Medical, LLC.

Primary DI
M75257029180
Brand
Stradis Medical, LLC.
Company
STRADIS MEDICAL, LLC
Model
570-2918
Published
2022-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
M75257029180PrimaryHIBCC0

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
770-962-2425SALES@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
10304040166885Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
00304040166888Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
H65857031365Henry ScheinHENRY SCHEIN, INC.PKE2022-08-10
H65857031361Henry ScheinHENRY SCHEIN, INC.PKE2022-08-10
M7526902620STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-21
M75257014820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
M7526902530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
10195594582845CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
50195594582843CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
M75257019510STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-03
M752KPX3209A0STRADIS 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
10888439831276CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
50888439831274CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
10888439782387CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
10888439795868CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439782385CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439795866CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
10888439793598CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
50888439793596CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
10888439678697CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
50888439678695CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
10888439766929CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
50888439766927CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
10888439771541CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02
50888439771549CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02
10888439629576CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-26
50888439629574CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-26