AccessGUDID - DEVICE: Sinuscope (04059082002835)

GUDID

Device Identifier (DI) Information

Brand Name: Sinuscope
Version or Model: 161 271 762BC001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SOPRO-COMEG GmbH

Primary DI Number: 04059082002835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 507185952 *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):	No
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 sinoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. 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 [?]
K944656	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: 842679f9-b3e4-4370-b9bc-b80cecda545a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 12, 2016