Arthrex Calcium Sulfate BioBeads, 5 cc ABS-3000-05

GUDID 00850018568081

BONE VOID FILLER

DIMENSIONAL BIOCERAMICS LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00850018568081
• NIH Device Record Key: cae94dcf-bbca-4094-b07a-5be003b8e23f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex Calcium Sulfate BioBeads, 5 cc
• Version Model Number: ABS-3000-05
• Catalog Number: ABS-3000-05
• Company DUNS: 080276169
• Company Name: DIMENSIONAL BIOCERAMICS 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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 Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018568081 [Primary]

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: 2023-09-13
• Device Publish Date: 2023-09-05

Devices Manufactured by DIMENSIONAL BIOCERAMICS LLC

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• 00850018568210 - G21 Flex Beads, 20cc: 2024-06-14 CALCIUM SULFATE BONE VOID FILLER
• 00850018568081 - Arthrex Calcium Sulfate BioBeads, 5 cc: 2023-09-13BONE VOID FILLER
• 00850018568081 - Arthrex Calcium Sulfate BioBeads, 5 cc: 2023-09-13 BONE VOID FILLER
• 00850018568098 - Arthrex Calcium Sulfate BioBeads, 10 cc: 2023-09-13 BONE VOID FILLER
• 00850018568180 - Arthrex Calcium Sulfate BioBeads, 20 cc: 2023-09-13 BONE VOID FILLER
• 00850018568005 - OsteoRepair-Paste: 2021-07-13 BONE VOID FILLER
• 00850018568012 - OsteoRepair-Paste: 2021-07-13 BONE VOID FILLER