AccessGUDID - DEVICE: HOPKINS (04048551193174)

GUDID

Device Identifier (DI) Information

Brand Name: HOPKINS
Version or Model: 7219AA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551193174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: HOPKINS® Telescope 0°, 2.7 mm, 18 cm

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
Rigid rhinoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasal cavity. It is inserted into the body through a nostril during rhinoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K945788	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
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: deee3932-e9e7-4121-9a3a-e640c5bb299e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016