Catalog Number

-

Brand Name

SNAP™

Version/Model Number

SNPA075US

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112341,K112341,K112341

Product Code

OKO

Product Code Name

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Public Device Record Key

c78faab3-b160-492a-aada-f18ee469b791

Public Version Date

September 09, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20849554006038

Quantity per Package

10

Contains DI Package

00849554006034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 PACK