Identity
- Trade Name
- Polygon FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- Polygon Resection Device - 9Fr/3 mm FDA UDI
- Model / Reference
- 50-100 FDA UDI
- Description
- Polygon Resection Device - 9Fr/3 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001020601 FDA UDI
- 510(k) Number
- K182675 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Tissue morcellation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDI
Category: Tissue morcellation system
Polygon by Polygon Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BLUEENDO — TROKAMED GmbH · 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
- Polygon Medical, Inc.
Sources (1)
- FDA UDI be0e24da-3e86-43c9-8efa-c4963acbab8a 36 fields · synced May 30, 2026