Aspiration Disposables Kit - LUMENIS LTD.

Duns Number:600166524

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More Product Details

Catalog Number

-

Brand Name

Aspiration Disposables Kit

Version/Model Number

Aspiration Disposables Kit

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

Yes

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

be08a81f-fad5-461a-bcd8-9f86f61c3ad5

Public Version Date

October 18, 2021

Public Version Number

5

DI Record Publish Date

September 07, 2016

Additional Identifiers

Package DI Number

17290109142040

Quantity per Package

6

Contains DI Package

07290109142043

Package Discontinue Date

-

Package Status

In Commercial Distribution

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