AccessGUDID - DEVICE: ENTEROSCOPE (04961333232925)

GUDID

Device Identifier (DI) Information

Brand Name: ENTEROSCOPE
Version or Model: VSB-3430K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PENTAX OF AMERICA, INC.

Primary DI Number: 04961333232925
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083211284 *Terms of Use

Device Description: SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED)

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Flexible video enteroscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy. It may be of a push-type, introduced by guidance under direct vision, or of a sonde type, which has an inflatable balloon that pulls it through the length of the intestine by peristalsis. 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 reusable device is used to examine strictures, Crohn's disease, or take biopsies.

GMDN Preferred Term Name

GMDN Definition

Flexible video enteroscope

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy. It may be of a push-type, introduced by guidance under direct vision, or of a sonde type, which has an inflatable balloon that pulls it through the length of the intestine by peristalsis. 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 reusable device is used to examine strictures, Crohn's disease, or take biopsies.

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962897	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant

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: 72cd9915-995c-468a-97e2-8a3f592d07e6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 06, 2017