AccessGUDID - DEVICE: V. Mueller (10885403009587)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: AU11395
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AU11395
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403009587
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller ROSEN FENESTROMETER GRADUATED IN MILLIMETERS, TO 4MM MAXIMUM OVERALL LENGTH 6-3/8" (16.2CM)

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
39987	Nasal depth gauge, reusable	A manual instrument designed for introduction into and measurement of the nasal cavities and paranasal sinuses during diagnostic and/or surgical procedures. It typically consists of a hand-held, slender, rod-like metallic device with a fine blunt distal end; the device usually includes rings (e.g., 3, 4, 5 mm) with calibrated diameters at its distal end to perform the measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYJ	GAUGE, MEASURING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: fa9ef2d1-988d-41c5-a9e7-db1d97387be4
Public Version Date: September 26, 2023
Public Version Number: 3
DI Record Publish Date: July 13, 2018