eyeMAX(TM) PB Digital Controller

GUDID 26932503571214

PB Digital Controller

Micro-Tech (Nanjing) Co., Ltd.

Flexible video choledochoscope, single-use
Primary Device ID26932503571214
NIH Device Record Keyf59c59e9-c53f-4f23-8b38-8ba05c9d29d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameeyeMAX(TM) PB Digital Controller
Version Model NumberBS-W-100
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS106932503571210 [Primary]
GS126932503571214 [Package]
Contains: 06932503571210
Package: CASE [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBNCholedochoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-05
Device Publish Date2025-04-25

Devices Manufactured by Micro-Tech (Nanjing) Co., Ltd.

16932503520673 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with
16932503520680 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with
16932503520697 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 2400mm,with
16932503520765 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with
16932503520772 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with
16932503520789 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 2400mm,with
16932503534694 - Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)2025-05-08 Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel:
16932503534700 - Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)2025-05-08 Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel:

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