Bicera® Resorbable Bone Substitute

GUDID 04719875722226

Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

WILTROM CO., LTD.

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• Primary Device ID: 04719875722226
• NIH Device Record Key: 41479968-5d29-49d9-990b-a36263fc5bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bicera® Resorbable Bone Substitute
• Version Model Number: BC-G20(2.0-3.0mm,0.25g)
• Company DUNS: 656680902
• Company Name: WILTROM CO., LTD.
• 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

Customer Support Contacts

• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719875722226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172237

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: 2021-01-06
• Device Publish Date: 2020-12-29

On-Brand Devices [Bicera® Resorbable Bone Substitute]

• 04719875722318: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
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• 04719875722226: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
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• 04719875722165: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722158: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722141: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722134: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722127: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722110: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
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• 04719875722080: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722073: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722066: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722059: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722042: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722035: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722028: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722011: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875722004: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875721991: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
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• 04719875721915: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst