AccessGUDID - DEVICE: R-GENIN Putty (00816125022144)

GUDID

Device Identifier (DI) Information

Brand Name: R-GENIN Putty
Version or Model: RG-02P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RG-02P
Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC

Primary DI Number: 00816125022144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081067703 *Terms of Use

Device Description: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calcium phosphate, and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. R-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.

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:	Yes
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?
61884	Cadaveric-donor/synthetic mineral bone graft	A sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is typically supplied as a kit which requires mixing to form a putty-like substance prior to implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQV	Filler, Bone Void, Calcium Compound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113791	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: abfeef3b-e6aa-40ae-9368-bd903c546b00
Public Version Date: December 23, 2019
Public Version Number: 5
DI Record Publish Date: April 10, 2016