ProLift Instruments 2019-0009

GUDID 00190837032203

Life Spine, Inc.

Metallic spinal interbody fusion cage
Primary Device ID00190837032203
NIH Device Record Keyc4afdbdf-ceeb-48bc-b7a9-447a97357939
Commercial Distribution StatusIn Commercial Distribution
Brand NameProLift Instruments
Version Model Number2019-0009
Catalog Number2019-0009
Company DUNS183641617
Company NameLife Spine, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837032203 [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

[00190837032203]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

On-Brand Devices [ProLift Instruments]

001908370323022019-0021
001908370322962019-0020
001908370322722019-0016
001908370322652019-0015
001908370322582019-0014
001908370322412019-0013
001908370322342019-0012
001908370322272019-0011
001908370322102019-0010
001908370322032019-0009
001908370321972019-0008
001908370321802019-0007
001908370321352019-0002
001908370321282019-0001

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