R-GENIN Putty RG-02P

GUDID 00816125022144

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.

BERKELEY ADVANCED BIOMATERIALS, LLC

Cadaveric-donor/synthetic mineral bone graft

• Primary Device ID: 00816125022144
• NIH Device Record Key: abfeef3b-e6aa-40ae-9368-bd903c546b00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-GENIN Putty
• Version Model Number: RG-02P
• Catalog Number: RG-02P
• Company DUNS: 081067703
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816125022144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113791

FDA Product Code

• MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-04-10

On-Brand Devices [R-GENIN Putty]

• 00816125022175: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calciu
• 00816125022168: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calciu
• 00816125022151: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calciu
• 00816125022144: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calciu
• 00816125022137: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calciu
• 00816125022120: R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calciu