Primary Device ID | 05060171623366 |
NIH Device Record Key | bc261bf0-5365-444a-8e4e-76468d119298 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ReproBone |
Version Model Number | RBM05 |
Company DUNS | 423459374 |
Company Name | CERAMISYS 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05060171623366 [Primary] |
LYC | Bone Grafting Material, Synthetic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-07-31 |
05060171623410 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 5cc |
05060171623403 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 3.0cc |
05060171623397 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 2.5cc |
05060171623380 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 2.0cc |
05060171623373 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 1.0cc |
05060171623366 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 0.5cc |
05060171623359 | ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 0.25cc |
05060171623342 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 5cc |
05060171623335 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 3.0cc |
05060171623328 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.5cc |
05060171623311 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.0cc |
05060171623304 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 1.0cc |
05060171623298 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 0.5cc |
05060171623281 | ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 0.25cc |