Catalog Number

SG 193-M

Brand Name

SG 193-M Reducing Adapter

Version/Model Number

SG 193-M

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

91637066-96dc-4bdd-99b3-2869a89aff80

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

September 08, 2017

Package DI Number

M996SG193M2

Quantity per Package

10

Contains DI Package

M996SG193M0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ziplock bag