FDA.reportPublic FDA data

Tuning Fork Metal Alloy C128

Primary DI
G25010067100
Brand
Tuning Fork Metal Alloy C128
Company
N S SURGICAL COMPANY
Model
10-067-10
Catalog number
10-067-10
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."
Published
2023-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWXFork, Tuning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWXFork, TuningNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G25010067100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tuning forkA 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 Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ultraviolet Light"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

Regulatory Flags#

DUNS number
645681649
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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