G21 Flex Beads, 10cc 900217 10

GUDID 00850018568203

CALCIUM SULFATE BONE VOID FILLER

DIMENSIONAL BIOCERAMICS LLC

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00850018568203
• NIH Device Record Key: 23957733-5326-4e38-99ea-2443ea74d768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G21 Flex Beads, 10cc
• Version Model Number: 900217 10
• Catalog Number: 900217 10
• 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: true
• 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: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018568203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171161

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: 2024-06-14
• Device Publish Date: 2024-06-06

Devices Manufactured by DIMENSIONAL BIOCERAMICS LLC

• 00850018568197 - G21 Flex Beads, 5cc: 2024-06-14 CALCIUM SULFATE BONE VOID FILLER
• 00850018568203 - G21 Flex Beads, 10cc: 2024-06-14CALCIUM SULFATE BONE VOID FILLER
• 00850018568203 - G21 Flex Beads, 10cc: 2024-06-14 CALCIUM SULFATE BONE VOID FILLER
• 00850018568210 - G21 Flex Beads, 20cc: 2024-06-14 CALCIUM SULFATE BONE 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