SNARE

Primary DI
07290015518086
Brand
SNARE
Company
MEDI-TATE LTD
Model
MT-SA21
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic HyperplasiaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190020000iTind SystemMedi-Tate , Ltd.2020-02-25QKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015518086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015518086072900155180867290015518086

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal urethral stent, short-termA sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is made entirely of metal [e.g., nickel-titanium alloy (Nitinol)] and is typically self-expanded in situ; disposable devices intended to assist implantation or removal (e.g., attached thread) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972777006745info@itind.com

Regulatory Flags#

DUNS number
532003626
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015518192iTind Removal KitMT-FA082023-10-25
07290015518062iTIND SystemMT-FA042020-11-10
07290015518079iTINDMT-SA202020-11-10
07290015518109iTIND SystemMT-FA052020-11-10
17290015518083Snare X5MT-FA092021-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290015518192iTind Removal KitMEDI-TATE LTDQKA2023-10-25
17290015518083Snare X5MEDI-TATE LTDQKA2021-07-20
07290015518062iTIND SystemMEDI-TATE LTDQKA2020-11-10
07290015518079iTINDMEDI-TATE LTDQKA2020-11-10
07290015518109iTIND SystemMEDI-TATE LTDQKA2020-11-10