Catalog Number

ONE4000

Brand Name

ONE Snare®

Version/Model Number

00884450121276

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

K122088,K122088,K122088

Product Code

MMX

Product Code Name

Device, percutaneous retrieval

Public Device Record Key

69504280-2463-40f3-995a-9a2fb6c515ec

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884450121270

Quantity per Package

20

Contains DI Package

10884450121273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-