Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Rigid endoscope telescope FDA UDI
- Device Name
- SCOPE, CABOT LAPAROCATOR FDA UDI
- Model / Reference
- 002399-501 FDA UDI
- Description
- SCOPE, CABOT LAPAROCATOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925000186 FDA UDI
- PMA Number
- P870076 FDA UDI
- FDA Product Code
- KNH FDA UDI
- GMDN Term
- Rigid endoscope telescope FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 884.5380 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 III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P870076 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 41dcda1c-e459-4d80-b219-27d890bff8f3 35 fields · synced May 31, 2026