Bicera® Resorbable Bone Substitute

GUDID 04719873027606

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. (Chutung)

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 04719873027606
• NIH Device Record Key: d89f1ab5-25d5-4c8a-b2f1-0cff6b6df361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bicera® Resorbable Bone Substitute
• Version Model Number: BC-B01(5x5x20mm,2c.c.)
• Company DUNS: 658742740
• Company Name: Wiltrom Co., Ltd. (Chutung)
• 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	04719873027606 [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]

• 04719873027729: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720147: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720130: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720123: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720116: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720109: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720093: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720086: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720079: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720055: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720048: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720031: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720024: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720017: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719875720000: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029990: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029983: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029976: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029969: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029945: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029938: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029921: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029914: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029907: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029891: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029884: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873029877: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027712: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027705: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027699: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027682: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027675: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027668: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027651: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027644: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027637: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027620: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027613: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst
• 04719873027606: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst