Identity
- Trade Name
- Accessory box AB-LT01 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Accessory Set including: 5pcs. 101014 Probe Tip PT-LT 1pc. 100160 Test Cavity PT-S 10pcs. 101035 Ear Tip Soft ET-LT10F 10pcs. 101036 Ear Tip Soft ET-LT14F 10pcs. 101037 Ear Tip ET-LT35 10pcs. 101038 Ear Tip ET-LT40 10pcs. 101311 Ear Tip ET-LT8T 10pcs. 101312 Ear Tip ET-LT13T 10pcs. 101365 Ear Tip ET-LT40G 15pcs. 101366 Ear Tip ET-LT45G 15pcs. 101367 Ear Tip ET-LT50G 10pcs. 101368 Ear Tip ET-LT60M 3pcs. 100186 Filter disk 1pc. 100151 Cleaning Tool CT-01 FDA UDI
- Model / Reference
- 101043 FDA UDI
- Description
- Accessory Set including: 5pcs. 101014 Probe Tip PT-LT 1pc. 100160 Test Cavity PT-S 10pcs. 101035 Ear Tip Soft ET-LT10F 10pcs. 101036 Ear Tip Soft ET-LT14F 10pcs. 101037 Ear Tip ET-LT35 10pcs. 101038 Ear Tip ET-LT40 10pcs. 101311 Ear Tip ET-LT8T 10pcs. 101312 Ear Tip ET-LT13T 10pcs. 101365 Ear Tip ET-LT40G 15pcs. 101366 Ear Tip ET-LT45G 15pcs. 101367 Ear Tip ET-LT50G 10pcs. 101368 Ear Tip ET-LT60M 3pcs. 100186 Filter disk 1pc. 100151 Cleaning Tool CT-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223144912 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 AB-LT01 by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (2)
- FDA UDI 805c3fac-08b0-46e0-a384-de603bd256b4 33 fields · synced Jun 14, 2026
- EUDAMED 1 fields · synced Jun 14, 2026