FDA.reportPublic FDA data

EndoRotor® XT Catheter 3.2mm x 1270mm

Primary DI
00854172008056
Brand
EndoRotor® XT Catheter 3.2mm x 1270mm
Company
INTERSCOPE, INC
Model
ER 10-03-F-S
Catalog number
ER 10-03-F-S
Published
2019-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00854172008056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854172008056008541720080568541720080560854172008056

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system handpiece, line-poweredA hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.

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
Expiration 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
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
00854172008049EndoRotor® Roll StandERC 20-04ERC 20-042019-08-19
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
00854172008049EndoRotor® Roll StandINTERSCOPE, INCPTE2019-08-19
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
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