Primary Device ID | B562PKBVF100 |
NIH Device Record Key | 0ed59cea-61ca-46c3-8d24-eca8ab709cd3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WISHBONE MG |
Version Model Number | PK-BVF10 |
Company DUNS | 062355158 |
Company Name | WISHBONE MEDICAL, INC. |
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 | true |
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 |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B562PKBVF100 [Primary] |
MQV | Filler, Bone Void, Calcium Compound |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-09 |
Device Publish Date | 2020-07-01 |
B562PKBVF150 | WISHBONE MG BONE VOID FILLER KIT, 15CC |
B562PKBVF100 | WISHBONE MG BONE VOID FILLER KIT, 10CC |
B562PKBVF050 | WISHBONE MG BONE VOID FILLER KIT, 5CC |
B562PKBVF000 | MIXING AND DELIVERY SYSTEM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WISHBONE MG 97918353 not registered Live/Pending |
Wishbone Medical, Inc. 2023-05-03 |