AccessGUDID - DEVICE: Stimulan Kit 5cc (CHINA ONLY) (15060155711567)

GUDID

Device Identifier (DI) Information

Brand Name: Stimulan Kit 5cc (CHINA ONLY)
Version or Model: 600-005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155711567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: (CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be injected, digitally packed into open bone void/gap to cure in situ or placed into a mould, the mixture sets to form Stimulan® pellets. The biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days when used in accordance with the device labelling.

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":	Yes
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 [?]
K141830	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
Device Size Text, specify: 5cc

Device Record Status

Public Device Record Key: aec004c6-effd-4841-9ce7-ba4f29f290a2
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 12, 2022