FDA.reportPublic FDA data

Silicone T-Tube

Primary DI
00684995510005
Brand
Silicone T-Tube
Company
BENTEC MEDICAL OPCO, LLC
Model
SU130-1208
Device description
4 Fr. x 12 in L
Published
2023-10-20
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

Product Codes#

Code, Name table
CodeName
PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTTBiliary Catheter For Irrigation And Contrast Injection, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00684995510005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00684995510005006849955100056849955100050684995510005

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainA flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080524654
Device count
1
Premarket exempt
true
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
00684995510012Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510029Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510036Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510043Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510050Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510067Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510074Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510081Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510098Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00684995510104Silicone T-TubeBENTEC MEDICAL OPCO, LLCPTT2023-10-20
00801741018718Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
00801741018725Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
00801741018732Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
00801741018749Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
10801741018715Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
10801741018722Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
10801741018739Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12
10801741018746Bard® T-TubeC. R. Bard, Inc.PTT2017-10-12