DUALX DUAL PORTAL SERIAL DILATOR #5

GUDID B707MHSD20010

SERIAL DILATOR #5

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707MHSD20010
NIH Device Record Key749b2024-52bf-4853-a932-0208f84ecf40
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX DUAL PORTAL SERIAL DILATOR #5
Version Model NumberMHSD2001
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707MHSD20010 [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

[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


[B707MHSD20010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-08
Device Publish Date2023-05-31

On-Brand Devices [DUALX DUAL PORTAL SERIAL DILATOR #5]

B707MDSD20010SERIAL DILATOR #5
B707MHSD20010SERIAL DILATOR #5

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