Rocket

Primary DI
05055270977113
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R57008-00-FM
Catalog number
R57008-00-FM
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K844608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844608000SURGICRAFT COPELAND DISPOSABLEA.W. Showell (Surgicraft) , Ltd.1985-05-01HGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270977137PackageGS125In Commercial Distribution
05055270977113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270977137050552709771375055270977137
05055270977113050552709771135055270977113

GMDN Terms#

Term, Definition table
TermDefinition
Foetal scalp electrode, clipA sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a metallic clip electrode mounted on a small disk with a cable that may include a transducer. The clip is spring-loaded in a closed position until it is apposed on the foetal scalp, at which time the clip can be opened and released to a secure attachment. 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.

Regulatory Flags#

DUNS number
544313588
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055270982339RocketR54400-00-00R54400-00-002023-10-20
05055270982643RocketR54410-WB-DLR54410-WB-DL2023-10-23
05055270982667RocketR54400-00-RKR54400-00-RK2023-10-23
05055270984289RocketR57525-00-T2R57525-00-T22023-10-31
05055270983237RocketR54549-26-PKR54549-26-PK2023-10-23
05055270913999RocketR57525-00-GER57525-00-GE2016-09-07
05055270914002RocketR57525-00-HR57525-00-H2016-09-07
05055270914019RocketR57525-00-P1R57525-00-P12016-09-07
05055270914026RocketR57525-00-P2R57525-00-P22016-09-07
05055270914033RocketR57525-00-TR57525-00-T2016-09-07
05055270964618RocketR57525-00-EVR57525-00-EV2016-09-07
05055270966025RocketR57525-00-AKR57525-00-AK2016-09-07
05055270966056RocketR57525-00-ALR57525-00-AL2016-09-09
05055270966087RocketR57525-00-E2R57525-00-E22016-09-07
05055270966117RocketR57525-00-GSR57525-00-GS2016-09-07
05055270967466RocketR57525-00-ECR57525-00-EC2016-09-07
05055270971241RocketR57525-00-EDR57525-00-ED2016-09-07
05055270971579RocketR57525-00-ESR57525-00-ES2016-09-07
05055270988546RocketR57525-00-MER57525-00-ME2023-10-24
05055270988638RocketR57525-00-T3R57525-00-T32023-10-24

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
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
20884527002815KendallCardinal Health, Inc.HGP2016-09-24