MT

GUDID 16932503511275

Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 12mm/15mm/18mm, Working Length 2000mm,

Micro-Tech (Nanjing) Co., Ltd.

ERCP catheter, balloon, non-electrical, stone-retrieval
Primary Device ID16932503511275
NIH Device Record Key95df0c9a-c87f-4189-8320-78d18293f686
Commercial Distribution StatusIn Commercial Distribution
Brand NameMT
Version Model NumberSRB-T-12/15/18-20-G-B
Company DUNS530269083
Company NameMicro-Tech (Nanjing) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com

Device Dimensions

Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter
Balloon Diameter12 Millimeter
Balloon Diameter15 Millimeter
Balloon Diameter18 Millimeter
Catheter Working Length2000 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106932503511278 [Primary]
GS116932503511275 [Package]
Contains: 06932503511278
Package: BOX [1 Units]
In Commercial Distribution
GS126932503511272 [Package]
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGEStents, Drains And Dilators For The Biliary Ducts

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-14
Device Publish Date2022-12-31

On-Brand Devices [MT]

16932503540381Normal handle, Oval, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm
16932503540374Normal handle, Oval, with spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm
16932503540367Normal handle, Alligator, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 m
16932503540350Normal handle, Alligator, with spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm
16932503540343Normal handle, Oval, without spike, Single outer sheath, Uncoated, Two Wire, 2.3*2300 mm
16932503540336Normal handle, Oval, with spike, Single outer sheath, Uncoated, Two Wire, 2.3*2300 mm
16932503540329Normal handle, Alligator, without spike, Single outer sheath, Uncoated, Two Wire, 2.3*2300 mm
16932503540312Normal handle, Alligator, with spike, Single outer sheath, Uncoated, Two Wire, 2.3*2300 mm
16932503510117The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Angle tip,Norm
56932503540563New handle, Serrated, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3
56932503540556New handle, Serrated, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3
56932503540549New handle, Serrated, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*23
56932503540532New handle, Serrated, with spike, Single outer sheath, PE coated, Four-bar linkage,2.3*1800 mm
56932503540440New handle,Serrated, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*23
56932503540433New handle, Serrated, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1
56932503540426New handle, Serrated, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*2300
56932503540419New handle, Serrated, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1800
56932503540402New handle, Alligator, with spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*160
56932503540396New handle, Alligator, with spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*120
56932503540303New handle, Alligator forceps, without spike, Single outer sheath, PE coated, Two Wire, 2.4*2
56932503540297New handle, Alligator forceps, without spike, Single outer sheath, PE coated, Two Wire, 2.4*1
56932503540280New handle, Alligator forceps, with spike, Single outer sheath, PE coated, Two Wire, 2.4*2300
56932503540273New handle, Alligator forceps, with spike, Single outer sheath, PE coated, Two Wire, 2.4*1800
56932503540266New handle, Oval, with spike, Single outer sheath, PE coated, Four-bar linkage, 1.8*1600 mm ,
56932503540259New handle, Oval, without spike, Single outer sheath, PE coated, Four-bar linkage, 1.8*1600 m
56932503540242New handle, Alligator, with spike, Tapered outer sheath, PE coated, Four-bar linkage, 2.3*230
56932503540235New handle, Alligator, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*2300
56932503540228New handle, Alligator, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1800
56932503540211New handle, Alligator, without spike, Tapered outer sheath, PE coated, Four-bar linkage, 2.3*2
56932503540204New handle, Alligator, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*2
56932503540198New handle, Alligator, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1
56932503540181New handle, Alligator, with spike, Single outer sheath, PE coated, Four-bar linkage, 3.0*2300
56932503540174New handle, Alligator, without spike, Single outer sheath, PE coated, Four-bar linkage, 3.0*2
56932503540167New handle, Alligator, with spike, Tapered outer sheath, FEP coated, Four-bar linkage, 2.3*23
56932503540150New handle, Alligator, without spike, Tapered outer sheath, FEP coated, Four-bar linkage, 2.3
56932503540143New handle, Alligator, without spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*
56932503540136New handle, Alligator, without spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*
56932503540129New handle, Oval, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*2300 mm ,
56932503540112New handle, Oval, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1800 mm ,
56932503540105New handle, Oval, without spike, Tapered outer sheath, PE coated, Four-bar linkage, 2.3*2300
56932503540099New handle, Oval, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*2300 m
56932503540082New handle, Oval, without spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1800 m
56932503540075New handle, Oval, with spike, Single outer sheath, PE coated, Four-bar linkage, 3.0*2300 mm ,
56932503540068New handle, Oval, without spike, Single outer sheath, PE coated, Four-bar linkage, 3.0*2300 m
56932503540051New handle, Oval, with spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*1600 mm
56932503540044New handle, Oval, with spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*1200 mm
56932503540037New handle, Oval, without spike, Tapered outer sheath, FEP coated, Four-bar linkage, 2.3*2300
56932503540020New handle, Oval, without spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*1600
56932503540013New handle, Oval, without spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*1200
16932503562307Blue handle 2.3mm OD 2500mm length

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.