AccessGUDID - DEVICE: DirectOss™ (10841307122517)

GUDID

Device Identifier (DI) Information

Brand Name: DirectOss™
Version or Model: DXCA251005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DXCA251005
Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC

Primary DI Number: 10841307122517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868856969 *Terms of Use

Device Description: Anorganic Bovine Cancellous Bone (250-1000µm) - 0.5g

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?
47968	Dental bone matrix implant, animal-derived	A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) 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 used to fill bone cavities and defects and contains pores that 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
NPM	Bone Grafting Material, Animal Source

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151209	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
Special Storage Condition, Specify: Room Temperature (15°C/59°F to 25°C/77°F)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 250-1000µm, 0.5g

Device Record Status

Public Device Record Key: 669c2dad-b1bf-49e4-bc05-cec31a4f9426
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016