Catalog Number

SGSIZ-RTS-G 3

Brand Name

SG Gluteal Sizer

Version/Model Number

SGSIZ-RTS-G 3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K052505

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

a6e0680b-cf8b-4156-b863-6733f2961b39

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-