Primary Device ID | 00813909012902 |
NIH Device Record Key | d17f178f-b599-459f-9d4f-e77b5d9b484b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IRM 10.0cc |
Version Model Number | NP0610TX |
Catalog Number | NP0610TX |
Company DUNS | 828813290 |
Company Name | NOVABONE PRODUCTS, LLC |
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 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813909012902 [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 | 2024-06-05 |
Device Publish Date | 2024-05-28 |
00813909012889 - IRM 2.5cc | 2024-06-05 Synthetic bone void filler for orthopedic applications |
00813909012896 - IRM 5.0cc | 2024-06-05 Synthetic bone void filler for orthopedic applications |
00813909012902 - IRM 10.0cc | 2024-06-05Synthetic bone void filler for orthopedic applications |
00813909012902 - IRM 10.0cc | 2024-06-05 Synthetic bone void filler for orthopedic applications |
00813909012865 - Bioactive Strip 5.0cc | 2024-03-12 Synthetic bone void filler for orthopedic applications |
00813909012872 - Bioactive Strip 10.0cc Long | 2024-03-12 Bone void filler for orthopedic applications |
00813909012803 - Putty Syringe 2.5cc | 2023-12-11 Synthetic bone void filler for orthopedic applications |
00813909012810 - Putty Syringe 5.0cc | 2023-12-11 Synthetic bone void filler for orthopedic applications |
00813909012827 - Wound Matrix | 2023-12-11 Collagen wound dressing |