DEVICE: Neoscope (00851545007623)

Device Identifier (DI) Information

Neoscope
NFU 9
In Commercial Distribution

PROSURG INC
00851545007623
GS1

1
188684609 *Terms of Use
NEOFLEX-FLEXIBLE VIDEO URETEROSCOPE
CLOSE

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?
38689 Flexible video ureteroscope, reusable
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FAJ Cystoscope And Accessories, Flexible/Rigid
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120766 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 9.0 French
CLOSE

Device Record Status

8b172aec-da34-40d3-a35c-fe5521f1d90d
April 22, 2020
5
September 23, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10851545007620 1 00851545007623 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
408 945 4044
Prosurg_qa@sbcglobal.net
CLOSE