Identity
- Trade Name
- Bio-logic FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- Replacement Sinser Tips, white, for use with 580-SINSER insert earphones FDA UDI
- Model / Reference
- Sinser Tip White FDA UDI
- Description
- Replacement Sinser Tips, white, for use with 580-SINSER insert earphones FDA UDI
Identifiers
- Catalog Number
- 202160 FDA UDI
- Primary DI / UDI-DI
- 00382830052283 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Auditory stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory stimulator
Bio-logic by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Auditory stimulator.
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- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- Nucleus — Cochlear · Class III
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- OAE EarTips — Natus Medical Denmark ApS · Class I
- Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa
Cleared under the same submission
K031009 also covers:
K073626 also covers:
K083371 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI cfb4e9bb-e9a3-446c-a6eb-56b687aa09d7 36 fields · synced May 31, 2026