Hunstad Infiltration Handle with Spring - Hunstad Infiltration Handle with Spring - MENTOR TEXAS L.P.

Duns Number:167450993

Device Description: Hunstad Infiltration Handle with Spring

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More Product Details

Catalog Number

HUN-HAN-S

Brand Name

Hunstad Infiltration Handle with Spring

Version/Model Number

HUN-HAN-S

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

K981172

Product Code Details

Product Code

MUU

Product Code Name

System, suction, lipoplasty

Device Record Status

Public Device Record Key

41afb636-eba1-42df-997c-3df4f746dca7

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MENTOR TEXAS L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 128
3 A medical device with high risk that requires premarket approval 545
U Unclassified 514