Catalog Number

32-2105

Brand Name

DeRoyal

Version/Model Number

32-2105

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

4bccf8c1-6527-4c54-8659-fffd43820a0e

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756980093

Quantity per Package

10

Contains DI Package

00749756980098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case