FDA.reportPublic FDA data

Rocket

Primary DI
05055270974440
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R57424-VIP
Catalog number
R57424-VIP
Device description
Rocket HSG Catheter 7FG
Published
2023-10-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000340000HYSTALOG HSG CATHETERRocket Medical Plc2000-04-19HES

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270974457PackageGS110Not in Commercial Distribution
05055270974464PackageGS135Not in Commercial Distribution
05055270974440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270974457050552709744575055270974457
05055270974464050552709744645055270974464
05055270974440050552709744405055270974440

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine imaging medium catheterA flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). 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

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
05055270966148RocketROCKET MEDICAL PLCHES2023-10-31
05055270966155RocketROCKET MEDICAL PLCHES2023-10-31
05055270974457RocketROCKET MEDICAL PLCHES2023-10-31
05055270981370RocketROCKET MEDICAL PLCHES2023-10-24
05055270981387RocketROCKET MEDICAL PLCHES2023-10-24
00887517021472PRECICE® Plating SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.HES2020-01-06
00888937015805Kronner ManipujectorCoopersurgical, Inc.HES2019-01-31
20888937014765Kronner ManipujectorCoopersurgical, Inc.HES2019-01-31
00827002303683CookCOOK INCORPORATEDHES2016-11-04
10653405045465CORE DYNAMICSConmed CorporationHES2016-09-24
10653405045472CORE DYNAMICSConmed CorporationHES2016-09-24
00827002248137uVueCOOK INCORPORATEDHES2016-09-24
10885403045080V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045097V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045110V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045127V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403050084V. MuellerSTERIS CORPORATIONHES2016-09-24
20653405045479CORE DYNAMICSConmed CorporationHES2016-09-24
10885403045134V. MuellerCAREFUSION 2200, INCHES2016-09-24
00827002165755SholkoffCOOK INCORPORATEDHES2016-09-24
10827002171470CookCOOK INCORPORATEDHES2016-09-24
10827002174716CookCOOK INCORPORATEDHES2016-09-24
10827002174723CookCOOK INCORPORATEDHES2016-09-24
00827002175907CookCOOK INCORPORATEDHES2016-09-24
10827002178707CookCOOK INCORPORATEDHES2016-09-24
10827002248134uVueCOOK INCORPORATEDHES2016-09-24
00827002303973CookCOOK INCORPORATEDHES2016-09-24
30653405074728CORE DYNAMICSConmed CorporationHES2016-09-24
70885403159956V. MuellerSTERIS CORPORATIONHES2016-09-24
00827002104327MenciniCOOK INCORPORATEDHES2016-09-24