Identity
- Trade Name
- Y-TEC® FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Model / Reference
- 00884450248119 FDA UDI
Identifiers
- Catalog Number
- FR-300/A FDA UDI
- Primary DI / UDI-DI
- 00884450248119 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Rigid optical laparoscope
Y-Tec® by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical laparoscope.
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- CONMED — Conmed Corporation · Class II
- ELMED — ELMED INCORPORATED · 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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI ea570927-6bfd-4ca2-a88a-5c6ee2e0c5c7 33 fields · synced Jun 9, 2026