AHBP 2.5 gram

GUDID 10850391007075

ABYRX, INC.

Bone wax, synthetic
Primary Device ID10850391007075
NIH Device Record Key52e877e5-c188-4c7f-a6db-089357f9e28c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAHBP 2.5 gram
Version Model NumberHBP-2512
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 Kitfalse
Device Combination Producttrue
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
GS100850391007078 [Primary]
GS110850391007075 [Package]
Contains: 00850391007078
Package: [12 Units]
In Commercial Distribution

FDA Product Code

MTJWax,Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-14

Devices Manufactured by ABYRX, INC.

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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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