Putty Convenience Kit, 5cc PCK-05

GUDID 00858418003942

The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.

BERKELEY ADVANCED BIOMATERIALS, LLC

Orthopaedic cement spacer mould

• Primary Device ID: 00858418003942
• NIH Device Record Key: 6ce8d17a-b1cb-417f-8fe9-4e3532b8ffb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Putty Convenience Kit, 5cc
• Version Model Number: PCK-05
• Catalog Number: PCK-05
• 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	00858418003942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022622

FDA Product Code

• 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: 2016-10-07

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.