AccessGUDID - DEVICE: n.a. (04048551052730)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 12030F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551052730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Esophagoscope Tube, size 3.5

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
Oesophageal tube	A sterile, hollow cylinder that usually contains two balloons, one for the stomach and one for the oesophagus, which are inflated after the device has been inserted into the oesophagus to tampon bleeding oesophageal varices. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
EOX	ESOPHAGOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943667	000

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: 7779d8e5-3326-45a7-9d54-697a9d13c7ee
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016