FDA.reportPublic FDA data

EndoRotor® Specimen Trap

Primary DI
00854172008209
Brand
EndoRotor® Specimen Trap
Company
INTERSCOPE, INC
Model
EPR-TRAP
Catalog number
EPR-TRAP
Device description
EndoRotor® Specimen Trap
Published
2021-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10854172008206PrimaryGS10
00854172008209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085417200820610854172008206
00854172008209008541720082098541720082090854172008209

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. 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
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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
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
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