OSSIX™ Bone OXB0250
GUDID 07290015477222
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™
DATUM DENTAL LTD
Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic| Primary Device ID | 07290015477222 |
| NIH Device Record Key | 1390ac83-265a-4ee2-b927-a67c7d3bad04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIX™ Bone |
| Version Model Number | 0.250 cc |
| Catalog Number | OXB0250 |
| Company DUNS | 600170232 |
| Company Name | DATUM DENTAL 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 |
Device Dimensions
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Length | 10 Millimeter |
| Depth | 5 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290015477222 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163714
FDA Product Code
| NPM | Bone Grafting Material, Animal Source |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-31 |
On-Brand Devices [OSSIX™ Bone]
| 07290015477253 | OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material inte |
| 07290015477222 | OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material inte |
| 07290015477215 | OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material inte |
Trademark Results [OSSIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIX 87218457 not registered Live/Pending |
DATUM BIOTECH LTD. 2016-10-27 |
 OSSIX 86337784 not registered Dead/Abandoned |
DATUM BIOTECH LTD. 2014-07-15 |
 OSSIX 79329322 not registered Live/Pending |
Datum Dental Ltd. 2021-10-06 |
 OSSIX 78046990 2748651 Dead/Cancelled |
DATUM BIO TECH LTD. 2001-02-07 |
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