POSS - Gown, Surgical, Reinforced AAMI Level 4 XX-Large - EXACT MEDICAL MANUFACTURING, INC.

Duns Number:014464314

Device Description: Gown, Surgical, Reinforced AAMI Level 4 XX-Large w/ Towel

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More Product Details

Catalog Number

00403

Brand Name

POSS

Version/Model Number

00403

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

K120045,K120045

Product Code Details

Product Code

FYA

Product Code Name

Gown, Surgical

Device Record Status

Public Device Record Key

33308edb-c301-4c11-adc1-6ac2768c04d7

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

December 08, 2020

Additional Identifiers

Package DI Number

00850337007421

Quantity per Package

28

Contains DI Package

00850337007414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"EXACT MEDICAL MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 489