Stimulan® Dispenser - Stimulan® Calcium Sulfate Bone Void Filler - BIOCOMPOSITES LTD

Duns Number:424382307

Device Description: Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.

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More Product Details

Catalog Number

600-30-s1

Brand Name

Stimulan® Dispenser

Version/Model Number

600-30-s1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 02, 2020

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

K001724

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

08ac819a-9e9c-4bc5-8ce8-492c0d3cf113

Public Version Date

November 02, 2020

Public Version Number

4

DI Record Publish Date

May 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCOMPOSITES LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 89