XenMatrix AB Surgical Graft - XenMatrix AB Surgical Graft - Davol Inc.

Duns Number:001191048

Device Description: XenMatrix AB Surgical Graft

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More Product Details

Catalog Number

1152020

Brand Name

XenMatrix AB Surgical Graft

Version/Model Number

1152020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K133223

Product Code Details

Product Code

FTM

Product Code Name

Mesh, surgical

Device Record Status

Public Device Record Key

99a48a05-139c-42e0-bbc7-2a0c9b58f270

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAVOL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 348
3 A medical device with high risk that requires premarket approval 18