SSCOR QUICKDRAW® - Portable Suction Device - SSCOR, INC.

Duns Number:131254971

Device Description: Portable Suction Device

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More Product Details

Catalog Number

-

Brand Name

SSCOR QUICKDRAW®

Version/Model Number

2403

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

c419ed98-091e-45c7-b709-8f494204193d

Public Version Date

August 23, 2019

Public Version Number

4

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

B24524031

Quantity per Package

1

Contains DI Package

B24524030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SSCOR, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24