AccessGUDID - DEVICE: Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules (00852108006190)

GUDID

Device Identifier (DI) Information

Brand Name: Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules
Version or Model: 04-005-01-SAS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OST404
Company Name: CYTOPHIL, INC.

Primary DI Number: 00852108006190
Issuing Agency: GS1
Commercial Distribution End Date: November 07, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 024222105 *Terms of Use

Device Description: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.

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 [?]
Premarket Submission Number Not Available/Not Released

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 15 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.5 Milliliter

Device Record Status

Public Device Record Key: 66701d27-2170-42ab-b88e-d3fa104f0aae
Public Version Date: November 08, 2019
Public Version Number: 2
DI Record Publish Date: October 30, 2019