Identity
- Trade Name
- THL FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- THL 3.6 mm CANNULA ACCESS KIT CONSISTS OF 1 EACH OF: GYT-36CA THL 3.6 mm CANNULA ACCESS KIT GYT-275-DS 3.5 mm DIAGNOSTIC SHEATH FDA UDI
- Model / Reference
- GYT-36CAK FDA UDI
- Description
- THL 3.6 mm CANNULA ACCESS KIT CONSISTS OF 1 EACH OF: GYT-36CA THL 3.6 mm CANNULA ACCESS KIT GYT-275-DS 3.5 mm DIAGNOSTIC SHEATH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925002616 FDA UDI
- 510(k) Number
- K980972 FDA UDI
- FDA Product Code
- FHO FDA UDI
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Thl by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K980972 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 021c1014-9a14-488b-b558-6e32be1efe4e 35 fields · synced Jun 8, 2026