Montage Fast Set

GUDID 00850391007184

ABYRX, INC.

Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic Bone wax, synthetic
Primary Device ID00850391007184
NIH Device Record Key8e4fac34-2807-42b9-a6f6-7fb1de7b6610
Commercial Distribution StatusIn Commercial Distribution
Brand NameMontage Fast Set
Version Model NumberOS-MON-1001FS
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 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
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]
GS100850391007184 [Primary]

FDA Product Code

MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone
MTJWax, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

Devices Manufactured by ABYRX, INC.

00850391007092 - AHBP Press2021-02-22
00850391007184 - Montage Fast Set2021-02-22
00850391007184 - Montage Fast Set2021-02-22
00850391007221 - Montage Flowable 8cc2021-02-22
00850391007153 - Hemasorb 2.0 gram with Spatula2018-07-06 Product Box also contains OS-SPA DI 00850391007146
00850391007030 - Hemasorb 2.0 gram 2018-07-06
00850391007054 - Hemasorb Apply2018-07-06
00850391007160 - Hemasorb 1.0 gram with Spatula2018-07-06 Product Box also contain OS-SPA DI 00850391007146
00850391007146 - Abyrx Spatula2018-07-06

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