EndoRotor® Catheter 3.2mm x 1270mm ER 10-03-F

GUDID 00865830000282

INTERSCOPE, INC

Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered
Primary Device ID00865830000282
NIH Device Record Key3794f545-6460-4d0d-bba2-df741ab81e98
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoRotor® Catheter 3.2mm x 1270mm
Version Model NumberER 10-03-F
Catalog NumberER 10-03-F
Company DUNS968227913
Company NameINTERSCOPE, INC
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com
Phone1-800-461-4289
Emailinfo@interscopemed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100865830000282 [Primary]

FDA Product Code

PTEEndoscopic Morcellator Gastroenterology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-14
Device Publish Date2021-04-06

Devices Manufactured by INTERSCOPE, INC

00854172008100 - EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter2024-02-19 EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter
00854172008117 - EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter2024-02-19 EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter
00854172008254 - EndoRotor® Catheter Guide2024-02-19 EndoRotor® Catheter Guide
00854172008094 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope
00854172008124 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short Olympus
00854172008131 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long 2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long Olympus/Pentax
00854172008148 - EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Bronchoscope2021-04-14 EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Bronchoscope
00854172008155 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Fuji2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Fuji

Trademark Results [EndoRotor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOROTOR
ENDOROTOR
86447058 5423689 Live/Registered
Interscope, Inc.
2014-11-06
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.