AccessGUDID - DEVICE: AED (00848657020008)

GUDID

Device Identifier (DI) Information

Brand Name: AED
Version or Model: 32-4221ZV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Primary DI Number: 00848657020008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 839138955 *Terms of Use

Device Description: Resectoscope sheath for continuous irrigation with standard obturator with central valve 27 CH

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:	No
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?
35301	Resectoscope	An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJL	RESECTOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54d5aa4e-6dba-4c00-8388-00d4ac9c4d09
Public Version Date: October 22, 2018
Public Version Number: 4
DI Record Publish Date: June 30, 2017