OPTEFORM® Allograft Paste, 2cc 606-01-02

GUDID 10885862094223

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived
Primary Device ID10885862094223
NIH Device Record Key3f279b3c-d385-4de8-80d5-731fde0c0e78
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTEFORM® Allograft Paste, 2cc
Version Model Number005102
Catalog Number606-01-02
Company DUNS014520584
Company NameSurgalign Spine Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862094223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2015-11-06

Devices Manufactured by Surgalign Spine Technologies, Inc.

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00840311208968 - Cortera2024-09-11 Tab Adjuster, MIS, Proximal, T
00840311236923 - Streamline OCT2023-10-13 Ø3.2mm x 100mm CoCr Rod
00840311236930 - Streamline OCT2023-10-13 Ø3.2mm x 110mm CoCr Rod
00840311236947 - Streamline OCT2023-10-13 Ø3.2mm x 120mm CoCr Rod
00840311236954 - Streamline OCT2023-10-13 Ø3.2mm x 160mm CoCr Rod
00840311236961 - Streamline OCT2023-10-13 Ø3.2mm x 180mm CoCr Rod
00840311236978 - Streamline OCT2023-10-13 Ø3.2mm x 20mm CoCr Rod

Trademark Results [OPTEFORM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTEFORM
OPTEFORM
75567452 2392670 Live/Registered
EXACTECH, INC.
1998-10-09
OPTEFORM
OPTEFORM
75567452 2392670 Live/Registered
Exactech, Inc.
1998-10-09

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