DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 2.0mm

GUDID B707UNH40200

ROTATORY KERRISON PUNCH 2.0mm

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707UNH40200
NIH Device Record Key5aea1b55-cecd-4831-aaf9-b8284f49126e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX DUAL PORTAL ROTATORY KERRISON PUNCH 2.0mm
Version Model NumberUNH4020
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707UNH40200 [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

[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

Moist Heat or Steam Sterilization


[B707UNH40200]

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 ROTATORY KERRISON PUNCH 2.0mm]

B707UNH40200ROTATORY KERRISON PUNCH 2.0mm
B707UNH20200ROTATORY KERRISON PUNCH 2.0mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.