Striate+™

GUDID 09358206000036

ORTHOCELL LIMITED

Collagen dental regeneration membrane

Primary Device ID	09358206000036
NIH Device Record Key	f902df3f-fc43-4a3c-8cf1-8e8e21456003
Commercial Distribution Status	In Commercial Distribution
Brand Name	Striate+™
Version Model Number	OCG-405
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	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter
Width	40 Millimeter
Length	50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09358206000036 [Primary]
GS1	19358206000033 [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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