Catalog Number

-

Brand Name

Anrei

Version/Model Number

HG-II-5CVM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K201771

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

ac23ef7d-5900-4aa3-b065-c24680002f2f

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

November 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-