Identity
- Trade Name
- M620 TTS FDA UDI
- Generic Name
- Ophthalmic slit lamp, surgical FDA UDI
- Device Name
- Table Top System for M620 - for Leica surgical operating microscope system: M620 TTS FDA UDI
- Model / Reference
- 000000000010448213 FDA UDI
- Description
- Table Top System for M620 - for Leica surgical operating microscope system: M620 TTS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003525243 FDA UDI
- FDA Product Code
- FSO FDA UDI
- GMDN Term
- Ophthalmic slit lamp, surgical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4700 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic slit lamp, surgical
M620 Tts by Leica Microsystems (Schweiz) AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic slit lamp, surgical.
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- Leica Keratoscope — Leica Microsystems (Schweiz) AG · Class I
- M620 F20 — Leica Microsystems (Schweiz) AG · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Leica Microsystems (Schweiz) AG
Sources (1)
- FDA UDI 27abe33f-fece-4d19-9235-f82f695dc335 36 fields · synced May 30, 2026