Pro Advantage - PA GAUZE SPONGE 3X3 8PLY NS 200/SLV 20SLV/CS - - NATIONAL DISTRIBUTION & CONTRACTING, INC.

Duns Number:009831413

Device Description: PA GAUZE SPONGE 3X3 8PLY NS 200/SLV 20SLV/CS - (CS)

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More Product Details

Catalog Number

P157116

Brand Name

Pro Advantage

Version/Model Number

P157116

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Device Record Status

Public Device Record Key

49c6431d-720d-4f71-9908-f6f4d9a96784

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Additional Identifiers

Package DI Number

M220P1571165

Quantity per Package

20

Contains DI Package

M220P1571163

Package Discontinue Date

-

Package Status

In Commercial Distribution

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