AccessGUDID - DEVICE: Stimulan® Pellets (15060155710058)

GUDID

Device Identifier (DI) Information

Brand Name: Stimulan® Pellets
Version or Model: 600-30-005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 600-30-005
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155710058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use
Previous DI: 50601557100516

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQV	Filler, Bone Void, Calcium Compound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001724	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 45 Degrees Celsius
Storage Environment Temperature: between 39 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 3 Millimeter
Device Size Text, specify: 5cc

Device Record Status

Public Device Record Key: 308fbf4e-21e5-46b7-a3ae-48ddd07ca692
Public Version Date: January 15, 2020
Public Version Number: 1
DI Record Publish Date: January 07, 2020