DualX Inserter Outer Shaft

GUDID B70712535015A0

DualX Inserter Outer Shaft

AMPLIFY SURGICAL, INC.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB70712535015A0
NIH Device Record Key941b49d6-8eb6-49fe-b830-5aa2fbd63e11
Commercial Distribution StatusIn Commercial Distribution
Brand NameDualX Inserter Outer Shaft
Version Model Number12535015A0
Company DUNS081021000
Company NameAMPLIFY SURGICAL, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-220-1286
Emailadmin@innovasiveinc.com
Phone949-220-1286
Emailadmin@innovasiveinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB70712535015A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B70712535015A0]

Moist Heat or Steam Sterilization


[B70712535015A0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-13
Device Publish Date2019-01-08

On-Brand Devices [DualX Inserter Outer Shaft]

B70712535015A0DualX Inserter Outer Shaft
B707125350150DUALX INSERTER OUTER SHAFT ASSEMBLY

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