CemSyntek Putty Convenience Kit 2.5cc ZS9213K-2

GUDID 00816125026128

The CemSyntek 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: 00816125026128
• NIH Device Record Key: b254c6c6-09f0-4157-8002-04b72b716c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CemSyntek Putty Convenience Kit 2.5cc
• Version Model Number: ZS9213K-2
• Catalog Number: ZS9213K-2
• 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	00816125026128 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-09
• Device Publish Date: 2025-05-01

Devices Manufactured by BERKELEY ADVANCED BIOMATERIALS, LLC

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• 00816125025572 - BiSyntek Granules: 2025-05-09 Granule Size: 0.5-1mm Volume: 1cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-t
• 00816125025589 - BiSyntek Granules: 2025-05-09 Granule Size: 0.5-1mm Volume: 2.5cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta
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• 00816125025602 - BiSyntek Granules: 2025-05-09 Granule Size: 1-3mm Volume: 10cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tr
• 00816125025619 - BiSyntek Granules: 2025-05-09 Granule Size: 1-6mm Volume: 15cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tr
• 00816125025626 - BiSyntek Granules: 2025-05-09 Granule Size: 1-6mm Volume: 20cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tr
• 00816125025633 - BiSyntek Granules: 2025-05-09 Granule Size: 1-6mm Volume: 30cc BiSyntek Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tr