AccessGUDID - DEVICE: Shefabone™ (05060517850005)

GUDID

Device Identifier (DI) Information

Brand Name: Shefabone™
Version or Model: SCPC Granules
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCPC-1
Company Name: SHEFABONE INC

Primary DI Number: 05060517850005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080521608 *Terms of Use

Device Description: Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosphate (NaCaPO4) and silica (SiO2). The two phases are sintered together in the form of solid solutions.The SCPC is in the form of porous particles in the size range 90-710 micron.The device is sterlized by Gama radiation.

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?
47971	Dental bone matrix implant, synthetic	A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone Grafting Material, Synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153230	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Centiliter

Device Record Status

Public Device Record Key: af7e9331-40b9-44d0-8248-a440d8a444ad
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 18, 2017