Identity
- Trade Name
- Lateral Mixing Tips FDA UDI
- Generic Name
- Earmould impression kit FDA UDI
- Device Name
- Lateral Mixing Tip Kit (contains 7 Mixing Tips for 10ml Cartridges) FDA UDI
- Model / Reference
- IDT05 FDA UDI
- Description
- Lateral Mixing Tip Kit (contains 7 Mixing Tips for 10ml Cartridges) FDA UDI
Identifiers
- Catalog Number
- IDT05 FDA UDI
- Primary DI / UDI-DI
- 00850013007509 FDA UDI
- FDA Product Code
- LDG FDA UDI
- GMDN Term
- Earmould impression kit 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Earmould impression kit
Lateral Mixing Tips by Earlens Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould impression kit.
- T Mixing canulas — Dreve Otoplastik GmbH · Class I
- Impression pads — Dreve Otoplastik GmbH · Class I
- Otoform® Kc — Dreve Otoplastik GmbH · Class I
- Mixing canulas — Dreve Otoplastik GmbH · Class I
- Otoform® Ak — Dreve Otoplastik GmbH · Class I
- T Mixing canulas — Dreve Otoplastik GmbH · Class I
- T Mixing canulas — Dreve Otoplastik GmbH · Class I
- Hardener paste — Dreve Otoplastik GmbH · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Earlens Corporation
Sources (1)
- FDA UDI 160e7f28-b118-4b5a-876e-ae0a8357dfaa 34 fields · synced May 30, 2026