Identity
- Trade Name
- otosil ES-1.1 FDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Device Name
- ES-1.1 / 25 Shore black-opaque 8 double cartridges with 48 ml each FDA UDI
- Model / Reference
- Shore 25 / 8 double cartridges of 2 x 24 ml - black opaque FDA UDI
- Description
- ES-1.1 / 25 Shore black-opaque 8 double cartridges with 48 ml each FDA UDI
Identifiers
- Catalog Number
- A0030376 FDA UDI
- Primary DI / UDI-DI
- EPRCA0030376 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Earmould, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Earmould, custom-made
otosil ES-1.1 by Pro3Dure Medical — 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
- Pro3Dure Medical
Sources (1)
- FDA UDI 33f86187-42cd-40a5-aa32-288bec901cd7 35 fields · synced Jun 1, 2026