AccessGUDID - DEVICE: Sorrento Bone Graft Substitute Strip (10cc) (B064HB11600201)

GUDID

Device Identifier (DI) Information

Brand Name: Sorrento Bone Graft Substitute Strip (10cc)
Version or Model: HB-116-0020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XENCO MEDICAL LLC

Primary DI Number: B064HB11600201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079282130 *Terms of Use

Device Description: CORRECTION: Sorrento Bone Graft Substitute Strip (20cc) 10cm x 2.5cm x .8cm (20cc), Alphatec Neocore Osteoconductive Matrix 100mm x 25mm x 8mm (20cc)

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?
46425	Bone matrix implant, animal-derived, bioabsorbable	A sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) 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 bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. 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 [?]
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: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff3012d3-f297-4d6c-ba91-360aeed290d5
Public Version Date: December 29, 2023
Public Version Number: 3
DI Record Publish Date: October 16, 2015