AccessGUDID - DEVICE: n.a. (04048551322550)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 13991SSE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551322550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Connector, for biopsy & working channel

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
Surgical instrument cleaning adaptor, reusable	A device intended to connect the lumen of an appropriate surgical instrument (e.g., an endoscope), or other cleaning tool, to the tubing of a device washer/decontaminator, or a tap, to facilitate an improved intraluminal flush and/or other cleaning of a surgical instrument. It is typically used for pre-cleaning (i.e., removal of gross blood and other organic debris) prior to disinfection or sterilization. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical instrument cleaning adaptor, reusable

A device intended to connect the lumen of an appropriate surgical instrument (e.g., an endoscope), or other cleaning tool, to the tubing of a device washer/decontaminator, or a tap, to facilitate an improved intraluminal flush and/or other cleaning of a surgical instrument. It is typically used for pre-cleaning (i.e., removal of gross blood and other organic debris) prior to disinfection or sterilization. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
FDF	Colonoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063585	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 9907a1d6-b91b-4ed7-9f07-27c6de9f2d48
Public Version Date: February 21, 2019
Public Version Number: 5
DI Record Publish Date: September 23, 2016