Striate+™
GUDID 09358206000005
ORTHOCELL LIMITED
Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane| Primary Device ID | 09358206000005 |
| NIH Device Record Key | a7119405-6120-402d-9893-99a34b0675b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Striate+™ |
| Version Model Number | OCG-152 |
| 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 | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
| Width | 15 Millimeter |
| Length | 20 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09358206000005 [Primary] |
| GS1 | 19358206000002 [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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