Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- RIGID SINUSCOPE 2.7 MM, 70 DEGREES AUTOCLAVABLE FDA UDI
- Model / Reference
- 70230915 FDA UDI
- Description
- RIGID SINUSCOPE 2.7 MM, 70 DEGREES AUTOCLAVABLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925026407 FDA UDI
- 510(k) Number
- K874215 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical sinoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K874215 also covers:
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 532097e8-f426-483b-9762-da7ed9263dee 35 fields · synced May 29, 2026