FDA.reportPublic FDA data

Silicone Biliary Stent

Primary DI
00684995500037
Brand
Silicone Biliary Stent
Company
BENTEC MEDICAL OPCO, LLC
Model
GR83064-02
Published
2017-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844384000BILIARY STENT PROSTHESISMentor Corp.1985-02-14FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00684995500037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00684995500037006849955000376849955000370684995500037

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080524654
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00684995300316Silicone Sheeting, Non-ReinforcedPR72034-60N2023-10-20
00684995310261Silicone Sheeting, ReinforcedPR72034-015SPR2023-10-20
10684995300009Silicone Sheeting Non-ReinforcedPR72034-66N2017-01-11
10684995300016Silicone Sheeting Non-ReinforcedPR72034-62N2017-01-11
10684995300023Silicone Sheeting Non-ReinforcedPR72034-64N2017-01-11
10684995300030Silicone Sheeting Non-ReinforcedPR72034-51N2017-01-11
10684995300047Silicone Sheeting Non-ReinforcedPR72034-52N2017-01-11
10684995300054Silicone Sheeting Non-ReinforcedPR72034-53N2017-01-11
10684995300061Silicone Sheeting Non-ReinforcedPR72034-54N2017-01-11
10684995300078Silicone Sheeting Non-ReinforcedPR72034-20N2017-01-11
10684995300085Silicone Sheeting Non-ReinforcedPR72034-21N2017-01-11
10684995300092Silicone Sheeting Non-ReinforcedPR72034-22N2017-01-11
10684995300108Silicone Sheeting Non-ReinforcedPR72034-23N2017-01-11
10684995300115Silicone Sheeting Non-ReinforcedPR72034-24N2017-01-11
10684995310008Silicone Sheeting ReinforcedPR72034-51R2017-01-11
10684995310015Silicone Sheeting ReinforcedPR72034-52R2017-01-11
10684995310022Silicone Sheeting ReinforcedPR72034-53R2017-01-11
10684995310039Silicone Sheeting ReinforcedPR72034-54R2017-01-11
10684995310046Silicone Sheeting ReinforcedPR72034-55R2017-01-11
10684995310169Silicone Sheeting ReinforcedPR72034-60R2017-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27