MENTOR Tissue Expander - Smooth Round, 700cc - MENTOR TEXAS L.P.

Duns Number:167450993

Device Description: Smooth Round, 700cc

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More Product Details

Catalog Number

350-4304M

Brand Name

MENTOR Tissue Expander

Version/Model Number

3504304M

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

K842883

Product Code Details

Product Code

LCJ

Product Code Name

EXPANDER, SKIN, INFLATABLE

Device Record Status

Public Device Record Key

66a4c699-9564-4697-8552-5519b5960cb5

Public Version Date

February 11, 2021

Public Version Number

5

DI Record Publish Date

September 14, 2015

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