Catalog Number

SC4JH

Brand Name

EXMOOR

Version/Model Number

SC4JH

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

bf40633c-0347-4f39-9447-dc2d79122c4e

Public Version Date

May 20, 2022

Public Version Number

1

DI Record Publish Date

May 12, 2022

Package DI Number

05060180251055

Quantity per Package

10

Contains DI Package

05060180258269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box