FDA.reportPublic FDA data

Rocket

Primary DI
05055270979322
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R56215-M
Catalog number
R56215-M
Device description
Rocket Rectal Solution Set
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FCEEnema Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270979322PackageGS125In Commercial Distribution
05055270979308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270979322050552709793225055270979322
05055270979308050552709793085055270979308

GMDN Terms#

Term, Definition table
TermDefinition
Rectal medication applicator, single-useA non-sterile instrument intended to be inserted into the rectum for the application of medication to treat local or systemic disease/conditions. It is a plastic device which may be in the form of a short tube to be connected to a cream medication tube, or a fluted tube with a plunger to administer a suppository. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544313588
Device count
1
DM exempt
false
Premarket exempt
true
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
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
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEASSOMEDIKA, OOOFCE2026-05-26
16971919462528Medi GradeNingbo Albert Novosino Co.,Ltd.FCE2025-12-29
00661392042483LSL HEALTHCARELSL Industries, LLCFCE2025-10-30
00661392011649LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
10661392011646LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
00661392000902LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
10661392000909LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
10827989007694Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
10827989007700Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
10192253028997DoverCardinal Health 200, LLCFCE2025-01-16
10192253029017DoverCardinal Health 200, LLCFCE2025-01-16
50192253028995DoverCardinal Health 200, LLCFCE2025-01-16
50192253029015DoverCardinal Health 200, LLCFCE2025-01-16
07333387024769Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052601Navina™ Classic System RefillWellspect ABFCE2025-01-10
07333387052625Navina™ Smart SystemWellspect ABFCE2025-01-10
07333387052564Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052779Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052816Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052830Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052878Navina™ Mini Start SetWellspect ABFCE2024-10-28
07333387052854Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052823Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052847Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052885Navina™ Mini Start SetWellspect ABFCE2024-10-28
06971919461395PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
06971919461401PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
05055270979308RocketROCKET MEDICAL PLCFCE2023-10-24
07333387029313Navina™ Classic System ConeWellspect ABFCE2023-09-25
07333387029702Navina™ Classic System Cone RefillWellspect ABFCE2023-09-25