Striate+™
GUDID 09358206000012
ORTHOCELL LIMITED
Collagen dental regeneration membrane| Primary Device ID | 09358206000012 |
| NIH Device Record Key | 56ed09fa-99c0-4dfe-af21-3f05cc4a1d86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Striate+™ |
| Version Model Number | OCG-203 |
| Company DUNS | 754598449 |
| Company Name | ORTHOCELL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09358206000012 [Primary] |
| GS1 | 19358206000019 [Package] Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201241
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 | 2021-05-05 |
| Device Publish Date | 2021-04-27 |
On-Brand Devices [Striate+™]
| 09358206000036 | OCG-405 |
| 09358206000029 | OCG-304 |
| 09358206000012 | OCG-203 |
| 09358206000005 | OCG-152 |
Trademark Results [Striate+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRIATE+ 79308964 not registered Live/Pending |
Orthocell Limited 2021-02-22 |
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