Identity
- Trade Name
- Mectascope FDA UDI
- Generic Name
- Rigid endoscope telescope FDA UDI
- Device Name
- MectaScope - Scope 30°, Ø4 L=18cm Autoclavable HD FDA UDI
- Model / Reference
- 05.17.10.0001 FDA UDI
- Description
- MectaScope - Scope 30°, Ø4 L=18cm Autoclavable HD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630040733502 FDA UDI
- 510(k) Number
- K200067 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Rigid endoscope telescope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Category: Rigid endoscope telescope
Mectascope by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Cleared under the same submission
K200067 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
- Medacta International
Sources (1)
- FDA UDI ba3bb772-2d2c-4965-9e8a-7ba2db85106e 34 fields · synced May 30, 2026