Goldtrace One

GUDID 20814247020745

Goldtrace One Fetal Spiral Electrode

CLINICAL INNOVATIONS, LLC

Foetal scalp electrode, spiral
Primary Device ID20814247020745
NIH Device Record Keyba923297-1974-4d42-804c-301af2b67d64
Commercial Distribution StatusIn Commercial Distribution
Brand NameGoldtrace One
Version Model NumberCNS000008
Company DUNS809524291
Company NameCLINICAL INNOVATIONS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814247020741 [Primary]
GS110814247020748 [Package]
Contains: 00814247020741
Package: [25 Units]
In Commercial Distribution
GS120814247020745 [Package]
Contains: 10814247020748
Package: [4 Units]
In Commercial Distribution

FDA Product Code

HGPElectrode, Circular (Spiral), Scalp And Applicator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

Devices Manufactured by CLINICAL INNOVATIONS, LLC

10814247021196 - FSE2023-10-05 Fetal Spiral Electrode
00814247021205 - FSE Cables2023-10-05 DECG Reusable Legplate Adapter Cable
10814247020120 - babyLance2023-04-24 Preemie (Pink/White) 0.85 mm depth, Safety Heelstick
10814247020168 - babyLance2023-04-24 Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick
10814247020182 - babyLance2023-04-24 Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick
10814247021127 - ABBy2023-04-24 ABBy Panniculus Retractor - 05 Regular
10814247021134 - ABBy2023-04-24 ABBy Panniculus Retractor - 05 Extra Large
10814247021141 - ABBy2023-04-24 ABBy Panniculus Retractor - 10 Regular

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