FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M75257032300
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
570-3230
Published
2022-12-19
Public version status
New
Distribution status
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
OJFHysterectomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75257032300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; 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
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
10198956492103CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956492363CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956496330CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956498389CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956525504CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956526020CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10198956488069CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10193489412796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413113Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489414783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489424249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489427813Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428483Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489430677Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489431650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489432688Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489448498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489450422Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-04-02
10193489950052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489432701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-06-05
10193489950298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489952810Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27