Catalog Number

-

Brand Name

Cranberry

Version/Model Number

S3160K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

Yes

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

53933ec9-3a50-47b0-8979-78a62fc0ee11

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

Package DI Number

20817508023271

Quantity per Package

8

Contains DI Package

10817508023274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case