AccessGUDID - DEVICE: Vitoss BBTrauma (00808232001327)

GUDID

Device Identifier (DI) Information

Brand Name: Vitoss BBTrauma
Version or Model: 2102-2202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2102-2202
Company Name: Stryker Corporation

Primary DI Number: 00808232001327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149183167 *Terms of Use

Device Description: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass

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?
47967	Bone matrix implant, composite	A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	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 [?]
K103173	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: Ambient
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Do Not Expose to Extreme Heat
Special Storage Condition, Specify: Do Not Freeze

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Total Volume: 2.5 Cubic Centimeter

Device Record Status

Public Device Record Key: 254fe0e6-9047-4066-8ddc-114847a1d589
Public Version Date: November 03, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2015