perFORM™

GUDID 09358206000098

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

Primary Device ID	09358206000098
NIH Device Record Key	e4795ef4-6b61-4947-9548-af46f2a50f4e
Commercial Distribution Status	In Commercial Distribution
Brand Name	perFORM™
Version Model Number	perf2030
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09358206000098 [Primary]
GS1	19358206000095 [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	2023-04-26
Device Publish Date	2023-04-18

On-Brand Devices [perFORM™]

09358206000104	perf3040
09358206000098	perf2030
09358206000081	perf1520

Trademark Results [perFORM]

Mark Image Registration \| Serial	Company Trademark Application Date
PERFORM 98401712 not registered Live/Pending	Total Performance Consulting, LLC 2024-02-12
PERFORM 97395518 not registered Live/Pending	HEART IP HOLDINGS LIMITED 2022-05-04
PERFORM 97307724 not registered Live/Pending	Medline Industries, LP 2022-03-11
PERFORM 97131609 not registered Live/Pending	A&E Television Networks, LLC 2021-11-18
PERFORM 90727482 not registered Live/Pending	MAKE GREAT SALES LIMITED 2021-05-21
PERFORM 90062095 not registered Live/Pending	Mantis Innovation Group, LLC 2020-07-20
PERFORM 88447671 not registered Live/Pending	Tornier, Inc. 2019-05-27
PERFORM 87351293 not registered Dead/Abandoned	Construction Linka Inc./Linka Construction Inc. 2017-02-27
PERFORM 87105938 5635447 Live/Registered	Mueller Sports Medicine, Inc. 2016-07-15
PERFORM 86829198 5147789 Live/Registered	IBACOS, INC. 2015-11-23
PERFORM 86829178 5143000 Live/Registered	IBACOS, INC. 2015-11-23
PERFORM 86743161 not registered Dead/Abandoned	Candescent Health, Inc. 2015-08-31