V.A.C.® - Vac Abdominal Dressing Featuring Sensatrac - KCI USA, INC.

Duns Number:102726734

Device Description: Vac Abdominal Dressing Featuring Sensatrac Technology

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More Product Details

Catalog Number

-

Brand Name

V.A.C.®

Version/Model Number

M8275080/5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 08, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022011,K022011

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

b4a1da48-cb07-4f6a-b5b2-7ccd900cf363

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

00878237001424

Quantity per Package

5

Contains DI Package

00849554002562

Package Discontinue Date

June 08, 2018

Package Status

Not in Commercial Distribution

Package Type

5 PACK

"KCI USA, 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. 63