DualX Inserter Handle

GUDID B707125350180

DualX Inserter Handle

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707125350180
NIH Device Record Key665cc7eb-0990-4202-8415-e2349a2cedcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameDualX Inserter Handle
Version Model Number12535018
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

Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707125350180 [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

[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


[B707125350180]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-20
Device Publish Date2021-08-12

On-Brand Devices [DualX Inserter Handle]

B70712535016A0DualX Inserter Handle
B707125350160DualX Inserter Handle Rev C
B707125350180DualX Inserter Handle
B707125350170DualX Inserter Handle

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