Identity
- Trade Name
- Accessory box AB03 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Accessory Set including: 4pcs. 100013 Probe Tip PT-A 4pcs. 100014-W Probe Tip PT-S 1pc. 100129 Test Cavity PT-A 1pc. 100160 Test Cavity PT-S 10pcs. 100063 Ear Tip ET-03 10pcs. 100064 Ear Tip ET-10 7pcs 100125 Ear Tip ET-11 5pcs. 100839 Ear Tip Soft ET-17 6pcs. 100838 Ear Tip Soft ET-16 10pcs. 100144 Ear Tip ET-13 4pcs. 100230 Ear Tip Soft ET-14 10pcs. 100030 Ear Tip ET-S02 10pcs. 100031 Ear Tip ET-S03 10pcs. 100032 Ear Tip ET-S10 10pcs. 100840 Ear Tip Soft ET-S11 1pc. 100151 Cleaning Tool CT-01 FDA UDI
- Model / Reference
- 100261 FDA UDI
- Description
- Accessory Set including: 4pcs. 100013 Probe Tip PT-A 4pcs. 100014-W Probe Tip PT-S 1pc. 100129 Test Cavity PT-A 1pc. 100160 Test Cavity PT-S 10pcs. 100063 Ear Tip ET-03 10pcs. 100064 Ear Tip ET-10 7pcs 100125 Ear Tip ET-11 5pcs. 100839 Ear Tip Soft ET-17 6pcs. 100838 Ear Tip Soft ET-16 10pcs. 100144 Ear Tip ET-13 4pcs. 100230 Ear Tip Soft ET-14 10pcs. 100030 Ear Tip ET-S02 10pcs. 100031 Ear Tip ET-S03 10pcs. 100032 Ear Tip ET-S10 10pcs. 100840 Ear Tip Soft ET-S11 1pc. 100151 Cleaning Tool CT-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223140730 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Evoked-potential audiometer
Accessory box AB03 by PATH medical GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI e58f9f72-82ab-4409-9e34-8a4c2e406c65 33 fields · synced Jun 1, 2026