CoLink View

GUDID 00817906027907

Tranverse Drill Guide Assembly, 3.5 Screw

IN2BONES USA, LLC

Orthopaedic fixation implant alignment tool
Primary Device ID00817906027907
NIH Device Record Key5d58b8ad-35fa-4625-bc58-03ae906789ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoLink View
Version Model NumberP04 N0191
Company DUNS079700711
Company NameIN2BONES USA, LLC
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
GS100817906027907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817906027907]

Moist Heat or Steam Sterilization


[00817906027907]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-22
Device Publish Date2018-10-22

On-Brand Devices [CoLink View]

00817906027907Tranverse Drill Guide Assembly, 3.5 Screw
00817906027891Insert Driver, Assy

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