Identity
- Trade Name
- Tuning Fork Metal Alloy C128 FDA UDI
- Generic Name
- Tuning fork FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10-067-10 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 10-067-10 FDA UDI
- Primary DI / UDI-DI
- G25010067100 FDA UDI
- FDA Product Code
- GWX FDA UDI
- GMDN Term
- Tuning fork FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Centimeter FDA UDI
Category: Tuning fork
Tuning Fork Metal Alloy C128 by N S Surgical Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- N S Surgical Company
Sources (1)
- FDA UDI 5d43ef8d-70d4-4bcd-965b-067e3f9bbde7 35 fields · synced Jun 1, 2026