FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M7526930030
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
693-003
Device description
CUSTOM SURGICAL KIT BREAST PACK, CONTAINS SUTURE
Published
2022-03-17
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
FTNKit, Plastic Surgery And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7526930030PrimaryHIBCC0

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@STRAISHEALTHCARE.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
10080196920846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2025-01-19
10193489425918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489434392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489214390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489214475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489215519Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489406696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489414936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489418828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419450Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419597Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419733Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489421743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424850Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489426311Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489427073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429299Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429305Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489439175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441635Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442687Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08