MEDLINE - Surgical irrigation/aspiration handpiece, - Modern Medical Equipment MFG. Ltd.

Duns Number:527812392

Device Description: Surgical irrigation/aspiration handpiece, single-use

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More Product Details

Catalog Number

-

Brand Name

MEDLINE

Version/Model Number

89056NS

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

FHF

Product Code Name

System, Evacuator, Fluid

Device Record Status

Public Device Record Key

3b979f91-e7d7-4f52-97b1-64272d55a8f0

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

December 16, 2017

Additional Identifiers

Package DI Number

26939029815174

Quantity per Package

4

Contains DI Package

16939029815177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MODERN MEDICAL EQUIPMENT MFG. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 165