Catalog Number

-

Brand Name

SNAP™

Version/Model Number

Snap Securring

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

K132080,K132080,K132080

Product Code

OKO

Product Code Name

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Public Device Record Key

011014b9-4885-4572-80ec-1b426c0d4ecc

Public Version Date

September 09, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

00849554005525

Quantity per Package

10

Contains DI Package

00849554006362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 PACK