InterGro DBM Paste - Demineralized Bone Matrix (DBM) in a Lipid Carrier - Biomet Orthopedics, LLC

Duns Number:129278169

Device Description: Demineralized Bone Matrix (DBM) in a Lipid Carrier

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More Product Details

Catalog Number

DBM002

Brand Name

InterGro DBM Paste

Version/Model Number

DBM002

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

K082793

Product Code Details

Product Code

GXP

Product Code Name

Methyl Methacrylate For Cranioplasty

Device Record Status

Public Device Record Key

6d60ac5d-f1bd-40cc-affa-b86a48dc971e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET ORTHOPEDICS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11962
2 A medical device with a moderate to high risk that requires special controls. 28376
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4