Catalog Number

-

Brand Name

Lewin Bone Holding Clamp

Version/Model Number

1100-427Q

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GDJ

Product Code Name

CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

e4cec690-4fbb-424a-8e68-05221a6d245c

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-