Catalog Number

-

Brand Name

Jigsaw Medical,LLC

Version/Model Number

SV1000-NSWC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Public Device Record Key

551cf431-26f7-4a5c-9c5c-fcc6086a6140

Public Version Date

February 24, 2022

Public Version Number

1

DI Record Publish Date

February 16, 2022

Package DI Number

00856274008613

Quantity per Package

12

Contains DI Package

00856274008606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case