FDA.reportPublic FDA data

EndoRotor® Roll Stand

Primary DI
00854172008049
Brand
EndoRotor® Roll Stand
Company
INTERSCOPE, INC
Model
ERC 20-04
Catalog number
ERC 20-04
Published
2019-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTEEndoscopic Morcellator Gastroenterology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTEEndoscopic Morcellator GastroenterologyObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854172008049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854172008049008541720080498541720080490854172008049

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous poleA metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Commonly known as an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed or operating table, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels to allow patient mobility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-461-4289info@interscopemed.com

Regulatory Flags#

DUNS number
968227913
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854172008100EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter6.0-PED-EGD6.0-PED-EGD2024-02-09
00854172008117EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter6.0-EPR-EGD6.0-EPR-EGD2024-02-09
00854172008254EndoRotor® Catheter GuideCATHGUIDECATHGUIDE2024-02-09
00865830000282EndoRotor® Catheter 3.2mm x 1270mmER 10-03-FER 10-03-F2021-04-06
00854172008001EndoRotor® Catheter 3.2mm x 1890mmER 10-01-OPER 10-01-OP2019-08-02
00854172008018EndoRotor® Catheter 3.2mm x 1540mmER 10-02-OER 10-02-O2019-08-02
00854172008032EndoRotor® Catheter 3.2mm x 1240mm ER 10-03-OPER 10-03-OP2019-08-02
00854172008056EndoRotor® XT Catheter 3.2mm x 1270mmER 10-03-F-SER 10-03-F-S2019-08-02
00854172008063EndoRotor® XT Catheter 3.2mm x 1890mmER 10-01-OP-SER 10-01-OP-S2019-08-02
00865830000206EndoRotor® 2200 CatheterER 10-03ER 10-032019-08-02
00865830000213EndoRotor® 2900 CatheterER 10-01ER 10-012019-08-02
00865830000268EndoRotor® 2550 CatheterER 10-02ER 10-022019-08-02
00865830000299EndoRotor® XT Catheter 3.2mm x 1240mm ER 10-03-OP-SER 10-03-OP-S2019-08-02
10854172008206EndoRotor® Specimen TrapEPR-TRAPEPR-TRAP2021-04-06
10854172008084EndoRotor® Purge Kit (Box of 10)ER 60-01ER 60-012021-03-31
00865830000237EndoRotor® Specimen Trap (Box of 50)ER 30-01ER 30-012019-08-02
00865830000244EndoRotor® Specimen Trap (Single)ER 30-01ER 30-012019-08-02
00854172008094EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope3.2-EPR-BRO-O3.2-EPR-BRO-O2021-04-06
00854172008124EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short3.2-EPR-COL-O3.2-EPR-COL-O2021-04-06
00854172008131EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long 3.2-EPR-COL-OP3.2-EPR-COL-OP2021-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854172008254EndoRotor® Catheter GuideINTERSCOPE, INCPTE2024-02-09
10854172008206EndoRotor® Specimen TrapINTERSCOPE, INCPTE2021-04-06
00854172008094EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – BronchoscopeINTERSCOPE, INCPTE2021-04-06
00854172008124EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope ShortINTERSCOPE, INCPTE2021-04-06
00854172008131EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long INTERSCOPE, INCPTE2021-04-06
00854172008148EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – BronchoscopeINTERSCOPE, INCPTE2021-04-06
00854172008155EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope FujiINTERSCOPE, INCPTE2021-04-06
00854172008162EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope OlympINTERSCOPE, INCPTE2021-04-06
00854172008179EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Colonoscope LonINTERSCOPE, INCPTE2021-04-06
00854172008186EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Gastroscope FujINTERSCOPE, INCPTE2021-04-06
00854172008193EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Gastroscope OlyINTERSCOPE, INCPTE2021-04-06
00854172008216EndoRotor® EndoSurgery System - ConsoleINTERSCOPE, INCPTE2021-04-06
00854172008230EndoRotor® PED Purge KitINTERSCOPE, INCPTE2021-04-06
00865830000282EndoRotor® Catheter 3.2mm x 1270mmINTERSCOPE, INCPTE2021-04-06
00854172008209EndoRotor® Specimen TrapINTERSCOPE, INCPTE2021-04-06
10854172008084EndoRotor® Purge Kit (Box of 10)INTERSCOPE, INCPTE2021-03-31
00854172008087EndoRotor® Purge Kit (Single)INTERSCOPE, INCPTE2021-03-30
00854172008070EndoRotor® Catheter 3.2mm x 760mmINTERSCOPE, INCPTE2020-05-29
00854172008001EndoRotor® Catheter 3.2mm x 1890mmINTERSCOPE, INCPTE2019-08-02
00854172008018EndoRotor® Catheter 3.2mm x 1540mmINTERSCOPE, INCPTE2019-08-02
00854172008032EndoRotor® Catheter 3.2mm x 1240mm INTERSCOPE, INCPTE2019-08-02
00854172008056EndoRotor® XT Catheter 3.2mm x 1270mmINTERSCOPE, INCPTE2019-08-02
00854172008063EndoRotor® XT Catheter 3.2mm x 1890mmINTERSCOPE, INCPTE2019-08-02
00865830000206EndoRotor® 2200 CatheterINTERSCOPE, INCPTE2019-08-02
00865830000213EndoRotor® 2900 CatheterINTERSCOPE, INCPTE2019-08-02
00865830000220EndoRotor® ConsoleINTERSCOPE, INCPTE2019-08-02
00865830000237EndoRotor® Specimen Trap (Box of 50)INTERSCOPE, INCPTE2019-08-02
00865830000244EndoRotor® Specimen Trap (Single)INTERSCOPE, INCPTE2019-08-02
00865830000251EndoRotor® Filter SetINTERSCOPE, INCPTE2019-08-02
00865830000268EndoRotor® 2550 CatheterINTERSCOPE, INCPTE2019-08-02