Catalog Number

-

Brand Name

Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)

Version/Model Number

SG-S2001S-XL

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"

-

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

K203539

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

058df747-5451-4ff5-9e95-c3f57bd9d12b

Public Version Date

March 28, 2022

Public Version Number

1

DI Record Publish Date

March 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-