Trel-X Gel - Trel-X™Gel, 5cc is human bone that has been - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: Trel-X™Gel, 5cc is human bone that has been demineralized and combined with poloxamer rev Trel-X™Gel, 5cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package.

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More Product Details

Catalog Number

TXG05

Brand Name

Trel-X Gel

Version/Model Number

TXG05

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)

Yes

FDA Premarket Submission

K040419

Product Code Details

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Device Record Status

Public Device Record Key

b6139ade-ff9f-4e0a-975c-ff20ea50473e

Public Version Date

October 02, 2020

Public Version Number

5

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 75
3 A medical device with high risk that requires premarket approval 17
U Unclassified 32