FDA.reportPublic FDA data

Stradis Medical, LLC.

Primary DI
M7526801010
Brand
Stradis Medical, LLC.
Company
STRADIS MEDICAL, LLC
Model
680-101
Published
2022-05-31
Public version status
New
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
MIBElastomer, Silicone Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7526801011PackageHIBCC100In Commercial Distribution
M7526801010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal tubeAn implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SALES@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
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
M7525250271STRADIS525-027525-0272016-05-04
M7525250291STRADIS525-029525-0292016-05-04
M752525021R11STRADIS525-0212016-09-10
M752525027R11STRADIS525-0272016-09-10
M752525028R11STRADIS525-0282016-09-17
M752525029R11STRADIS525-0292016-09-17
M752525037R11STRADIS525-0372016-09-17
M752525038R10Stradis Medical, LLC.525-038 R12017-04-12
M752525038R11STRADIS525-0382016-09-10
M752525038SAR11STRADIS525-038SA2016-09-10
M752525065R11STRADIS525-0652016-09-10
M752525072R11STRADIS525-0722016-09-10
M7525250791STRADIS525-079525-0792016-05-04
M752525079R11STRADIS525-0792016-09-10
M752525083R11STRADIS525-0832016-09-10
M7525251551STRADIS525-1552016-09-17
M752525202R11STRADIS525-2022016-09-10
M752525462R11STRADIS525-4622016-09-10
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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M724MHTBL10WFVS50101Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-08-25
M724MHTBL10WM301Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-08-25
M724MHTBL10WS201Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-08-25
M724MHTBL12GM301Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-08-25
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B097IMD009LLO1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2023-07-13
B097IMD009XL1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2023-07-13
B097IMD009XLO1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2023-07-13
B097IMD009XXL1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2023-07-13
B097IMD006LLO1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2019-02-15
B097IMD006XLO1Himplant Pre-Formed Penile Silicone BlockINTERNATIONAL MEDICAL DEVICES, INC.MIB2019-02-15
M724CCB11SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB12SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB13SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB14SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB15SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB21SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB22SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB23SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB31SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB32SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB33SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB41SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB42SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB43SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB44SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB45SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB50NS1ContourFlex™ Gluteal ImplantIMPLANTECH ASSOCIATES, INC.MIB2017-07-10