FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M7526702460
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
670-246
Published
2022-03-14
Public version status
Update
Distribution status
Not 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
OFUSpinal Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7526702461PackageHIBCC10In Commercial Distribution
M7526702460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

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
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10198956444362CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-21
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10198956359833CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-06
10198956359321CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
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10198956393349CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-19
10198956364622CARDINAL HEALTHCardinal Health 200, LLCOFU2026-02-09
10198956238732CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
10198956343603CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
10198956270749CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-29
10198956266513CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
10198956248595CARDINAL HEALTHCardinal Health 200, LLCOFU2025-11-06
10198956139978CARDINAL HEALTHCardinal Health 200, LLCOFU2025-10-13
10198956124639CARDINAL HEALTHCardinal Health 200, LLCOFU2025-10-03
10198956169593CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
10198956133693CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
10198956099630CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-20
10198956080652CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
10197106924136CARDINAL HEALTHCardinal Health 200, LLCOFU2025-04-03
10198956009653CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-31
10198956007246CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-25
10197106980248CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-14
10197106955468CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-11
10197106839355CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-10
10197106938515CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-28