Identity
- Trade Name
- Modus X FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- Robotic Exoscope FDA UDI
- Model / Reference
- SYN-0974 FDA UDI
- Description
- Robotic Exoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00670082000573 FDA UDI
- FDA Product Code
- EPT FDA UDI
- GMDN Term
- General-purpose surgical microscope 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: General-purpose surgical microscope
Modus X by Synaptive Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose surgical microscope.
- FIXED 45 DEGREE INCLINED BINOCULAR, A-SERIES, 10X EYEPIECES, F:160 — GLOBAL SURGICAL CORP. · Class I
- MAGEWELL IMAGE CAPTURE KIT WITH USB3 CABLE, AIRMOUSE, AND SOFTWARE — GLOBAL SURGICAL CORP. · Class I
- OSM200 Stand — Prescott'S, Inc. · Class I
- SILICONE EYEGUARD, LOW PROFILE, FOR OLD STYLE EYEPIECES — GLOBAL SURGICAL CORP. · Class I
- MICROSCOPE — Ecleris · Class I
- MICROSCOPE — Ecleris · Class I
- S7 / OPMI PROergo — Carl Zeiss Meditec AG · Class I
- A-SERIES CEILING MOUNT, STANDARD DROP CEILING — GLOBAL SURGICAL CORP. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synaptive Medical Inc
Sources (1)
- FDA UDI 9a0f464c-d0e8-4d96-a166-630b29ef4f2e 34 fields · synced Jun 1, 2026