Stimulan® Rapid Cure - STIMULAN® Rapid Cure provided sterile for single - BIOCOMPOSITES LTD

Duns Number:424382307

Device Description: STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contain STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.

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More Product Details

Catalog Number

620-020

Brand Name

Stimulan® Rapid Cure

Version/Model Number

620-020

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

K141830,K141830

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

ba98f3a1-3c65-4deb-8783-a886a656feb8

Public Version Date

January 15, 2020

Public Version Number

1

DI Record Publish Date

January 07, 2020

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