NA - Sterile disposable cover for WD261xx, 127 x 90 cm - MAVIG GmbH

Duns Number:317502326

Device Description: Sterile disposable cover for WD261xx, 127 x 90 cm (1 pouch)

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More Product Details

Catalog Number

STEA-WD261

Brand Name

NA

Version/Model Number

STEA-WD261

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"

-

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

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

32c748a8-0a97-4747-93cc-77d51d722326

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 05, 2017

Additional Identifiers

Package DI Number

04251339900097

Quantity per Package

20

Contains DI Package

04251339900103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MAVIG GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 15