InterOss® - SIGMAGRAFT, INC.

Duns Number:078893672

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More Product Details

Catalog Number

-

Brand Name

InterOss®

Version/Model Number

IOLGS050

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

K151209

Product Code Details

Product Code

NPM

Product Code Name

BONE GRAFTING MATERIAL, ANIMAL SOURCE

Device Record Status

Public Device Record Key

e366484b-6317-465d-a571-41efce4cae38

Public Version Date

October 03, 2018

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGMAGRAFT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14