TrelliForm - DSM BIOMEDICAL, INC.

Duns Number:131107757

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More Product Details

Catalog Number

TF0616

Brand Name

TrelliForm

Version/Model Number

30017-02

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FTM

Product Code Name

Mesh, Surgical

Device Record Status

Public Device Record Key

9664c1e3-a2d8-4e06-a700-aadf2836fe6d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DSM BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 132
U Unclassified 5