FDA.reportPublic FDA data

TAUT

Primary DI
24026704418910
Brand
TAUT
Company
TELEFLEX INCORPORATED
Model
IPN007865
Catalog number
50640
Published
2016-09-16
Public version status
Update
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
GCACATHETER, BILIARY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011018000TAUT BALLOON CATHETER, MODEL 50640Taut, Inc.2001-06-22GCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704418910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670441891024026704418910

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length86.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900093NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664900208NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901137NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901441NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901458NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902578NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902653NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902660NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903247NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903254NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903261NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664907528NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910689NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910696NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910726NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910733NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911006NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911013NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911082NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911099NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06970057571027Stone Extraction BalloonJiangsu Vedkang Medical Science and Technology Co.,Ltd.GCA2026-04-14
06948318963102AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
06948318963119AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
04711182608309Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
04711182608316Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09