Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Rigid optical cystoscope FDA UDI
- Device Name
- Biopsy Port Seal (6/PK) FDA UDI
- Model / Reference
- ACN-BP FDA UDI
- Description
- Biopsy Port Seal (6/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925038103 FDA UDI
- 510(k) Number
- K012929 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Rigid optical cystoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid optical cystoscope
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical cystoscope.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K012929 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 II | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI b01f3552-4216-4acc-b3b9-e526f844cac2 34 fields · synced May 30, 2026