FDA.report

FENTEX

Primary DI
04250407703752
Brand
FENTEX
Company
FENTEX medical GmbH
Model
038100FX
Catalog number
038100FX
Device description
Tuning Fork by Hartmann C = 128 Hz
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GWXFORK, TUNING

Product Code Classifications

CodeDeviceSpecialtyClass
GWXFork, TuningNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250407703752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250407703752042504077037524250407703752

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4974679496212s.renner@fentexmedical.com

Regulatory Flags

DUNS number
507221724
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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