AccessGUDID - DEVICE: PENTAX (04961333085132)

GUDID

Device Identifier (DI) Information

Brand Name: PENTAX
Version or Model: OF-B153
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOYA CORPORATION

Primary DI Number: 04961333085132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691519705 *Terms of Use

Device Description: No description.

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

GMDN Preferred Term Name	GMDN Definition
Surgical instrument cleaning adaptor	A non-sterile device intended to connect the tubing of a device washer/decontaminator to the lumen of an appropriate surgical instrument to facilitate an improved intraluminal flush of the instrument. It typically consists of a tubing adaptor designed to fit a specific surgical instrument (e.g., an endoscope). This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131902	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide
Moist Heat or Steam Sterilization
Sound Waves

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: 4033414b-08f2-4ffb-b351-3b382829fa07
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 07, 2017