Bicera® Resorbable Bone Substitute
GUDID 04719875720000
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| Primary Device ID | 04719875720000 |
| NIH Device Record Key | 55bf2751-224c-473e-9f9a-4fc4c4747035 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bicera® Resorbable Bone Substitute |
| Version Model Number | BC-G15(0.5-1.0mm,1g) |
| 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 |
| yichun@wiltrom.com.tw |
Operating and Storage Conditions
| Storage Environment Temperature | Between 23 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719875720000 [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 | 2019-09-18 |
| Device Publish Date | 2019-09-10 |
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 |
Trademark Results [Bicera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BICERA 98755203 not registered Live/Pending |
Penn-Troy Manufacturing, Inc. 2024-09-17 |
 BICERA 86609901 4974667 Live/Registered |
WILTROM CO., LTD. 2015-04-25 |
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