Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Hysteroscopic insufflator FDA UDI
- Device Name
- Fluid Pouch Disposable (12/PK) FDA UDI
- Model / Reference
- GY5-PCH FDA UDI
- Description
- Fluid Pouch Disposable (12/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925002630 FDA UDI
- 510(k) Number
- K905706 FDA UDI
- FDA Product Code
- HIG FDA UDI
- GMDN Term
- Hysteroscopic insufflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1700 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hysteroscopic insufflator
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hysteroscopic insufflator.
- HYSTEROFLATOR — Karl Storz GmbH & Co. KG · Class II
- DOLPHIN II — Gyrus Acmi, Inc. · Class II
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 80ee8dfe-63da-42ff-85de-969a20eba6d3 34 fields · synced Jun 6, 2026