AccessGUDID - DEVICE: Tuning Fork Metal Alloy C128 (G25010067100)

GUDID

Device Identifier (DI) Information

Brand Name: Tuning Fork Metal Alloy C128
Version or Model: 10-067-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-067-10
Company Name: N S SURGICAL COMPANY

Primary DI Number: G25010067100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645681649 *Terms of Use

Device Description: A hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is usually made of stainless steel in the form of a two-pronged fork with the prongs (tines) formed from a U-shaped bar with a handle attached at the base of the "U". It resonates at a specific constant pitch when set vibrating by striking it against a surface or with an object. The pitch that a particular tuning fork generates depends on the length of the two prongs. This is a reusable device.

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32526	Tuning fork	A hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is usually made of stainless steel in the form of a two-pronged fork with the prongs (tines) formed from a U-shaped bar with a handle attached at the base of the "U". It resonates at a specific constant pitch when set vibrating by striking it against a surface or with an object. The pitch that a particular tuning fork generates depends on the length of the two prongs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWX	Fork, Tuning

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
Ultraviolet Light
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 5d43ef8d-70d4-4bcd-965b-067e3f9bbde7
Public Version Date: May 08, 2023
Public Version Number: 1
DI Record Publish Date: April 29, 2023