Colorado Therapeutics Xenograft Implant - COLORADO THERAPEUTICS LLC

Duns Number:080356428

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More Product Details

Catalog Number

XI1116B-S+

Brand Name

Colorado Therapeutics Xenograft Implant

Version/Model Number

XI-S+

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

3fd9598f-39b0-4d57-9afd-c6ecbe4d0f0d

Public Version Date

September 20, 2019

Public Version Number

1

DI Record Publish Date

September 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLORADO THERAPEUTICS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12