Identity
- Trade Name
- MIS Inner Ear Suction Curette FDA UDI
- Generic Name
- Endaural surgical curette, reusable FDA UDI
- Device Name
- MIS Inner Ear Suction Curette Curved Oval 1.5 x 2.5 Millimeter With Suction Hole FDA UDI
- Model / Reference
- 412-940 FDA UDI
- Description
- MIS Inner Ear Suction Curette Curved Oval 1.5 x 2.5 Millimeter With Suction Hole FDA UDI
Identifiers
- Catalog Number
- 412-940 FDA UDI
- Primary DI / UDI-DI
- 00192896121829 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Endaural surgical curette, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Dry Heat Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 130 Millimeter FDA UDI
Category: Endaural surgical curette, reusable
MIS Inner Ear Suction Curette by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endaural surgical curette, reusable.
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- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- BEAR — Bear-Ent, LLC · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- gSource — GSOURCE, LLC. · 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 |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI d6e53e83-2811-4655-8fa7-374c6dae7403 36 fields · synced May 30, 2026