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AcuSpot

FDA UDI

Class II (US FDA UDI)

by Lumenis

Identity

Trade Name
AcuSpot FDA UDI
Generic Name
ENT surgery micromanipulator FDA UDI
Device Name
Additional DM DIs: 07290109144306 07290109144313 FDA UDI
Model / Reference
AcuSpot 712 Z Micromanipulator FDA UDI
Description
Additional DM DIs: 07290109144306 07290109144313 FDA UDI

Identifiers

Catalog Number
AC-0020170 FDA UDI
Primary DI / UDI-DI
07290109141954 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
ENT surgery micromanipulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: ENT surgery micromanipulator

AcuSpot by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT surgery micromanipulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lumenis

Sources (1)

  • FDA UDI b08f34e0-bb37-41c9-b771-e38892b975ac 35 fields · synced May 31, 2026