i2b Rapid Set, 10g C10 SB010

GUDID 00816125023554

i2bâ„¢ Rapid Set is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, i2bâ„¢ Rapid Set resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. i2bâ„¢ Rapid Set is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic

• Primary Device ID: 00816125023554
• NIH Device Record Key: b3e36aae-702d-41b4-b20c-485148028c3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i2b Rapid Set, 10g
• Version Model Number: C10 SB010
• Catalog Number: C10 SB010
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• 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	00816125023554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022622

FDA Product Code

• GXP: Methyl Methacrylate For Cranioplasty
• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-05-21

Devices Manufactured by BERKELEY ADVANCED BIOMATERIALS, LLC

• 00816125024766 - Bi-Ostetic Granules: 2024-10-09 Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe
• 00816125024728 - Bi-Ostetic Bioactive Glass Foam: 2024-08-27 Bi-Osteticâ„¢ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) â€
• 00816125024735 - Bi-Ostetic Bioactive Glass Foam: 2024-08-27 Bi-Osteticâ„¢ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) â€
• 00816125024742 - Bi-Ostetic Bioactive Glass Foam: 2024-08-27 Bi-Osteticâ„¢ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) â€
• 00816125024759 - Bi-Ostetic Bioactive Glass Foam: 2024-08-27 Bi-Osteticâ„¢ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) â€
• 00816125024704 - Synthetic Backfill Bioimplant Ø6.5 x 40mm: 2024-05-02 The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatit
• 00816125024711 - Synthetic Backfill Bioimplant Ø8.5 x 40mm: 2024-05-02 The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatit
• 00816125024353 - Putty Convenience Kit, 2.5cc: 2023-09-05 The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.