Trel-XC Putty - Trel-XC Putty, 5cc is a combination of human bone - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: Trel-XC Putty, 5cc is a combination of human bone that has been demineralized and cancello Trel-XC Putty, 5cc is a combination of human bone that has been demineralized and cancellous bone mixed with poloxamer reverse phase medium and formulated into a paste or putty-like form. Trel-XC is provided in a sterile, single patient use package.

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More Product Details

Catalog Number

TXCPY05

Brand Name

Trel-XC Putty

Version/Model Number

TXCPY05

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

K050642,K070751

Product Code Details

Product Code

MBP

Product Code Name

Filler, bone void, osteoinduction (w/o human growth factor)

Device Record Status

Public Device Record Key

f0276bf5-34ae-4c24-9fbc-b5047fd42b45

Public Version Date

September 22, 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