Arthrex® - STIMUBLAST GEL, 10CC - ARTHREX, INC.

Duns Number:131747628

Device Description: STIMUBLAST GEL, 10CC

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More Product Details

Catalog Number

ABS-2002-10

Brand Name

Arthrex®

Version/Model Number

ABS-2002-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2017

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

-

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

d843c9cb-167e-4841-9f08-a00d7db54b8d

Public Version Date

April 26, 2021

Public Version Number

8

DI Record Publish Date

February 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARTHREX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6506
2 A medical device with a moderate to high risk that requires special controls. 3411
3 A medical device with high risk that requires premarket approval 1
U Unclassified 2