Catalog Number

E6558N

Brand Name

Exact Medical Manufacturing

Version/Model Number

E6558N

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

-

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

165b7d62-c511-4eae-9d1d-10eb13c9fc8b

Public Version Date

December 17, 2021

Public Version Number

1

DI Record Publish Date

December 09, 2021

Package DI Number

10850033380887

Quantity per Package

1

Contains DI Package

00850033380880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case