Catalog Number

DNSC15747

Brand Name

Medline Industries, Inc.

Version/Model Number

DNSC15747

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

K982313

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

ce0f5993-18ec-4e33-a36c-9bd4e0a48056

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-