DUALX SCREW DRIVER 2

GUDID B707125350040

Dual X Screw Driver 2

Amplify Surgical, Inc.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device IDB707125350040
NIH Device Record Key1ef50f7e-6f0e-4d19-b73d-92e1c6542b40
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX SCREW DRIVER 2
Version Model Number12535004
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707125350040 [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

[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


[B707125350040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-05-21
Device Publish Date2020-11-09

On-Brand Devices [DUALX SCREW DRIVER 2]

B707125350040Dual X Screw Driver 2
B707125350060Dual X Screw Driver 2

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