Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Endoscopic light source adaptor FDA UDI
- Device Name
- TRANSPORT F/S&N AND STORZ SCOPES FDA UDI
- Model / Reference
- 70230643 FDA UDI
- Description
- TRANSPORT F/S&N AND STORZ SCOPES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925029910 FDA UDI
- 510(k) Number
- K932988 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Endoscopic light source adaptor 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
Yes
FDA UDI
Serial Number
No
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
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 |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 3326089c-c2de-48b3-8a5f-c5af408dd2fc 35 fields · synced May 30, 2026