DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR GENERAL

GUDID B707USCH10

SCOPE CANNULA SELF RETRACTOR GENERAL

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707USCH10
NIH Device Record Key103145f0-2f1c-454f-9b6f-44cb562bcf0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR GENERAL
Version Model NumberUSCH1
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
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
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707USCH10 [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

[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


[B707USCH10]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

On-Brand Devices [DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR GENERAL]

B707USCH10SCOPE CANNULA SELF RETRACTOR GENERAL
B707USCH1US0SCOPE CANNULA SELF RETRACTOR GENERAL US MANUFACTURE

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