NanoBone® SBX Putty
GUDID 14260418440512
Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix) embedded in an aqueous gel
Biocomposites GmbH
Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | 14260418440512 |
| NIH Device Record Key | b2f74a07-12c7-411c-bb17-288ee356a5e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NanoBone® SBX Putty |
| Version Model Number | 200051 |
| Company DUNS | 332760383 |
| Company Name | Biocomposites GmbH |
| 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 | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com | |
| Phone | +4903818069940 |
| infogermany@biocomposites.com |
Device Dimensions
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14260418440512 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190110
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 | 2023-11-30 |
| Device Publish Date | 2023-11-22 |
On-Brand Devices [NanoBone® SBX Putty ]
| 14260418440536 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
| 14260418440529 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
| 14260418440512 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
| 14260418440499 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
| 14260418440505 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
| 14260418440482 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
| 14260418440475 | Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered |
Trademark Results [NanoBone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NANOBONE 97318010 not registered Live/Pending |
ARTOSS GmbH 2022-03-17 |
 NANOBONE 85872393 4500633 Live/Registered |
ARTOSS GmbH 2013-03-11 |
 NANOBONE 79020406 3181225 Dead/Cancelled |
ARTOSS GmbH 2005-07-15 |
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