CoLink Mini

GUDID 00817906029543

Straight Plate, 6H, Trial

IN2BONES USA, LLC

Surgical implant template, reusable
Primary Device ID00817906029543
NIH Device Record Key30391f82-2b9d-45d3-8cd5-1449714eff27
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoLink Mini
Version Model NumberP09 N1016
Company DUNS079700711
Company NameIN2BONES USA, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100817906029543 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817906029543]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-07
Device Publish Date2019-09-27

On-Brand Devices [CoLink Mini]

00817906029574T-Plate, 7H, Trial
00817906029567T-Plate, 5H, Trial
00817906029550Straight Plate, 8H, Trial
00817906029543Straight Plate, 6H, Trial
00817906029536Straight Plate, 4H, Trial
00817906029529Straight Plate, 3H, Trial
00817906029512Straight Plate, 2H, Trial
00817906029505Oblique L Plate, 7H, Left, Trial
00817906029499Oblique L Plate, 7H, Right, Trial
00817906029482Oblique L Plate, 5H, Left, Trial
00817906029475Oblique L Plate, 5H, Right, Trial
00817906029468T-Plate, 7H
00817906029451T-Plate, 5H
00817906029444Straight Plate, 8H
00817906029437Straight Plate, 6H
00817906029420Straight Plate, 4H
00817906029413Straight Plate, 3H
00817906029406Straight Plate, 2H
00817906029390Oblique L Plate, 7H, Left
00817906029383Oblique L Plate, 7H, Right
00817906029376Oblique L Plate, 5H, Left
00817906029369Oblique L Plate, 5H, Right
00810021860329Locking Drill Guide, Ø1.9
00810021860312Locking Drill Guide, Ø1.6

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