DynaLink 125-697

GUDID 00190837104603

Screw Caddy

Life Spine, Inc.

Polymeric spinal fusion cage, non-sterile
Primary Device ID00190837104603
NIH Device Record Key1c98f627-9a93-4c60-a618-5eab83348344
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaLink
Version Model Number125-697
Catalog Number125-697
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
GS100190837104603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837104603]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [DynaLink]

001908371046273.5mm Ball End Hex Driver
00190837104610Barb Caddy
00190837104603Screw Caddy
00190837104580Modular Distractor Tip Right
00190837104573Modular Distractor Tip Left
00190837104566Fixed Angle Awl
001908371045594mm Hex Driver

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