Bicera® Resorbable Bone Substitute
GUDID 04719875722110
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.
Synthetic bone graft| Primary Device ID | 04719875722110 |
| NIH Device Record Key | d5393375-3bca-49f1-a04b-6e1f8b5aa357 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bicera® Resorbable Bone Substitute |
| Version Model Number | BC-G09(0.5-1.0mm,10c.c.) |
| 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 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| yichun@wiltrom.com.tw | |
| Phone | +88636107168 |
| 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 | 04719875722110 [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 |
| 04719875722301 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722295 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722288 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722271 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722264 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722257 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722240 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722233 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722226 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722219 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722202 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722196 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722189 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722172 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 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 |
| 04719875722103 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875722097 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 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 |
| 04719875721984 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721977 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721960 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721953 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721946 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721939 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721922 | Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of cryst |
| 04719875721915 | 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.