MENTOR MemoryGel BOOST Resterilizable Gel Sizer - Moderate Plus Profile BOOST, For Use With SMPB-130 - MENTOR TEXAS L.P.

Duns Number:167450993

Device Description: Moderate Plus Profile BOOST, For Use With SMPB-130

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

RSZ-MPB-130S

Brand Name

MENTOR MemoryGel BOOST Resterilizable Gel Sizer

Version/Model Number

RSZMPB130S

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"

Yes

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

K062421

Product Code Details

Product Code

MRD

Product Code Name

SIZER, MAMMARY, BREAST IMPLANT VOLUME

Device Record Status

Public Device Record Key

e62093b3-7a79-42d1-b850-f41f7c35c78d

Public Version Date

February 23, 2022

Public Version Number

1

DI Record Publish Date

February 15, 2022

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