Catalog Number

-

Brand Name

Drive

Version/Model Number

11117N-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 26, 2019

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILS

Product Code Name

ADAPTOR, HYGIENE

Public Device Record Key

edc4f461-b1db-44d5-bac4-0874db3b085d

Public Version Date

June 26, 2019

Public Version Number

3

DI Record Publish Date

July 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-