AccessGUDID - DEVICE: Neoscope (00851545007548)

GUDID

Device Identifier (DI) Information

Brand Name: Neoscope
Version or Model: NFC 17
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROSURG INC

Primary DI Number: 00851545007548
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188684609 *Terms of Use

Device Description: NEOFLEX -FLEXIBLE VIDEO CYSTOSCOPE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61728	Flexible video cystoscope, single-use	A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAS	Electrode, Electrosurgical, Active, Urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120766	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 17 French

Device Record Status

Public Device Record Key: 4760c08f-c7fa-45c2-9649-5ff12c7d72b4
Public Version Date: April 24, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016