FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M75257032290
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
570-3229
Published
2023-01-18
Public version status
New
Distribution status
Not 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
FTNPlastic Surgery And Accessories Kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75257032290PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Collection syringe adaptor, single-useA small sterile device designed be placed over the top of a syringe to encase the tip of the syringe as means to modify the shape and the size of the syringe tip. It is typically made of polymer material and its shape and size mimics that of the appropriately-matched syringe barrel (i.e., 60 cc, 30 cc, 10 cc versions of a Toomey style syringe). It is typically used for the transfer of human tissue or other substances from one container to another during plastic and reconstructive surgery, cosmetic surgery, or general surgery procedures. 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

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

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Primary DI, Brand, Company table
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