Pro Advantage - Pro Advantage Glutaraldehyde 28 Gallon - NATIONAL DISTRIBUTION & CONTRACTING, INC.

Duns Number:009831413

Device Description: Pro Advantage Glutaraldehyde 28 Gallon

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More Product Details

Catalog Number

N099002

Brand Name

Pro Advantage

Version/Model Number

N099002

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"

-

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

-

Product Code Details

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Device Record Status

Public Device Record Key

54a1d987-5ed9-4529-891e-9adf1a9e512e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

M220N0990025

Quantity per Package

4

Contains DI Package

M220N0990028

Package Discontinue Date

-

Package Status

-

Package Type

Case

"NATIONAL DISTRIBUTION & CONTRACTING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 224
2 A medical device with a moderate to high risk that requires special controls. 192