Abyrx Spatula

GUDID 00850391007146

ABYRX, INC.

Bone wax, synthetic
Primary Device ID00850391007146
NIH Device Record Key786c5717-ce7a-4518-b15c-99280dd1a694
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbyrx Spatula
Version Model NumberOS-SPA
Company DUNS078818942
Company NameABYRX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850391007146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTJWax,Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-24

Devices Manufactured by ABYRX, INC.

00850391007245 - Montage Settable Bone Putty2023-11-24
00850391007252 - Montage Settable Bone Putty2023-11-24
00850391007290 - Montage Flowable Settable Bone Paste2023-11-24 8cc Cartridge
00850391007306 - Montage Flowable Settable Bone Paste2023-11-24 Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 00850391007313, and Montage Flowable
00850391007313 - Montage Flowable Settable Bone Paste2023-11-24 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Fl
00850391007320 - Montage Flowable Settable Bone Paste2023-11-24 Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix
00850391007238 - Permatage 5cc2023-11-01
00850391007269 - Putty Applicator Gun2023-04-03

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