Hemasorb 2.0 gram with Spatula

GUDID 00850391007153

Product Box also contains OS-SPA DI 00850391007146

ABYRX, INC.

Bone wax, synthetic
Primary Device ID00850391007153
NIH Device Record Key27ebefbc-ad21-472d-aff5-ca45bd705af2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemasorb 2.0 gram with Spatula
Version Model NumberOS-201
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
GS100850391007023 [Primary]
GS100850391007153 [Package]
Contains: 00850391007023
Package: [1 Units]
In Commercial Distribution

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

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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
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