OSSIX® Breeze
GUDID 07290015477338
Cross-linked pericardium membrane
DATUM DENTAL LTD
Collagen dental regeneration membrane| Primary Device ID | 07290015477338 |
| NIH Device Record Key | b37e93a6-c9a4-4a32-b6d2-af77afe890e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIX® Breeze |
| Version Model Number | 68018007 |
| 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
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
| Width | 30 Millimeter |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290015477338 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212509
FDA Product Code
| NPL | Barrier, Animal Source, Intraoral |
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 | 2022-09-13 |
| Device Publish Date | 2022-09-05 |
On-Brand Devices [OSSIX® Breeze]
| 07290015477338 | Cross-linked pericardium membrane |
| 07290015477321 | Cross-linked pericardium membrane |
| 07290015477314 | Cross-linked pericardium membrane |
| 07290015477307 | Cross-linked pericardium membrane |
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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