DEVICE: EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long (00854172008131)

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Device Record History
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Device Identifier (DI) Information
EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long
3.2-EPR-COL-OP
In Commercial Distribution
3.2-EPR-COL-OP
INTERSCOPE, INC
00854172008131
GS1

1
968227913 *Terms of Use
EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long Olympus/Pentax
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46732 Tissue morcellation system handpiece, line-powered
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PTE Endoscopic Morcellator Gastroenterology
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
f65588bd-cefd-4c15-b373-289311be3a51
April 14, 2021
1
April 06, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-461-4289
info@interscopemed.com
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