00711401

GUDID 10816765011512

Cytology Brush Bronchoscope

US Endoscopy

Flexible endoscopic cytology brush, single-use
Primary Device ID10816765011512
NIH Device Record Keye292a435-c697-4016-b48b-f17f8ecb2d0e
Commercial Distribution Discontinuation2019-03-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number00711401
Catalog Number00711401
Company DUNS627879687
Company NameUS Endoscopy
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)769-8226
Emailglobal@usendoscopy.com
Phone+1(800)769-8226
Emailglobal@usendoscopy.com
Phone+1(800)769-8226
Emailglobal@usendoscopy.com

Device Dimensions

Length120 Centimeter
Length120 Centimeter
Length120 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816765011515 [Primary]
GS110816765011512 [Package]
Contains: 00816765011515
Package: Box [20 Units]
Discontinued: 2019-03-25
Not in Commercial Distribution

FDA Product Code

FDXendoscopic cytology brush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-25
Device Publish Date2016-09-17

Devices Manufactured by US Endoscopy

00724995244545 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244552 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244569 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244576 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244583 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244590 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244606 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm no wire is made of nylon and is a progressive stage balloon capable of th
00724995244613 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progressive stage balloon capable of th

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.