FDA.reportPublic FDA data

Goldtrace One

Primary DI
20814247020745
Brand
Goldtrace One
Company
CLINICAL INNOVATIONS, LLC
Model
CNS000008
Device description
Goldtrace One Fetal Spiral Electrode
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HGPElectrode, Circular (Spiral), Scalp And Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGPElectrode, Circular (Spiral), Scalp And ApplicatorObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030691000FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.2003-09-17HGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814247020748PackageGS125In Commercial Distribution
20814247020745PackageGS14In Commercial Distribution
00814247020741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081424702074810814247020748
2081424702074520814247020745
00814247020741008142470207418142470207410814247020741

GMDN Terms#

Term, Definition table
TermDefinition
Foetal scalp electrode, spiralA sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a spiralled (either single- or double-helix) metallic electrode with a sharp tip that is directly inserted into the foetal scalp with a screwing action; and an adaptor cable that may include a transducer. The electrode penetrates into the scalp up to 2.5 mm (0.1 inch); it is usually inserted with a dedicated applicator that may be included. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809524291
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814247021304Panniculus Retraction KitPRS-CK-05SM2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallPRS-CK-05MD2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargePRS-CK-05LG2026-05-31
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
00814247020369traxi® Panniculus Retractor ExtenderPRS-10502016-09-01
30814247020346traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetaiPRS-05302016-09-01
30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
00814247020802traxi® Panniculus RetractorPRS-EVAL2016-09-22
00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
00814247020178Koala®IPC-5000E2016-09-01
00814247020741Goldtrace OneCNS0000082016-09-01
00814247020505Spiral Fetal Scalp ElectrodeCNS0000042016-09-01
00814247020512FSE CablesSBT-70102016-09-01
00814247020529FSE CablesSBT-70112016-09-01
00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340154900027Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABHGP2026-03-06
07340154900010Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABHGP2026-03-06
10889483588406Vital Signs™AirLife Finland OyHGP2025-03-31
20889483588403Vital Signs™AirLife Finland OyHGP2025-03-31
05055270977113RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977144RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977137RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977168RocketROCKET MEDICAL PLCHGP2023-10-24
00814247021199FSECLINICAL INNOVATIONS, LLCHGP2023-09-27
10814247021196FSECLINICAL INNOVATIONS, LLCHGP2023-09-27
00814247021205FSE CablesCLINICAL INNOVATIONS, LLCHGP2023-09-27
10192253040500KendallCardinal Health 200, LLCHGP2022-05-27
10192253021158KendallCardinal Health 200, LLCHGP2021-02-23
50192253021156KendallCardinal Health 200, LLCHGP2021-02-23
10190752142176Vital Signs™AirLife Finland OyHGP2020-12-15
50190752142174Vital Signs™Vyaire Medical OyHGP2020-12-15
10192253020977KendallCardinal Health 200, LLCHGP2020-10-30
50192253020975KendallCardinal Health, Inc.HGP2020-10-30
B510FM30001ADVANCED FETAL MONITORADVANCED INSTRUMENTATIONS, INC.HGP2020-04-16
00884838007475NAPhilips Medical Systems HsgHGP2017-07-24
00884838007468NAPhilips Medical Systems HsgHGP2017-03-14
00884838007451Fetal MeasurementsPhilips Medical Systems HsgHGP2017-01-16
20884838007431Fetal MeasurementsPhilips Medical Systems HsgHGP2016-11-08
10885403252204N/ACarefusion Finland 320 OyHGP2016-10-17
20885403252201N/ACarefusion Finland 320 OyHGP2016-10-17
10884521081123KendallCardinal Health, Inc.HGP2016-09-24
10884527004911KendallCardinal Health, Inc.HGP2016-09-24
20884527002822KendallCardinal Health, Inc.HGP2016-09-24
20884521081120KendallCardinal Health, Inc.HGP2016-09-24
20884527004918KendallCardinal Health, Inc.HGP2016-09-24