AcuPulse™ Upgrade Kit 40AES-F to 40AES-R - Additional DM - LUMENIS LTD.

Duns Number:600166524

Device Description: Additional DM UDI:07290109144054;07290109144047;07290109144078;07290109144122

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More Product Details

Catalog Number

-

Brand Name

AcuPulse™ Upgrade Kit 40AES-F to 40AES-R

Version/Model Number

AcuPulse™ Upgrade Kit 40AES-F to 40AES-R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

fdcfcc11-d8dd-4dc5-9a9d-8aa54c236af1

Public Version Date

February 27, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUMENIS LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 361