FDA.reportPublic FDA data

Rocket

Primary DI
05055270979643
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R57686
Catalog number
R57686
Device description
Filter Set for Oocyte Aspiration Pump
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
true
Single use
true

Product Codes#

Code, Name table
CodeName
NVTTubing And Tubing/Filter Fits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVTTubing And Tubing/Filter FitsObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270979643PackageGS110In Commercial Distribution
05055270979650PackageGS12In Commercial Distribution
05055270979636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270979643050552709796435055270979643
05055270979650050552709796505055270979650
05055270979636050552709796365055270979636

GMDN Terms#

Term, Definition table
TermDefinition
Suction system filter, microbialA screening device intended to be installed within a suction system and which has a membrane pore size small enough to retain bacterial pathogens, thus preventing the environment from becoming infected and decreasing the risk of cross-infection to subsequent patients. It is typically directly connected to the suction system collection bottle/canister, or as a common filter serving more than one bottle/canister through a switching mechanism, or in a tubing line between the suction bottle/canister and the suction pump, or at the suction pump exhaust where driving gases are discarded. 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
07613327626469ThermaClearSTRYKER CORPORATIONNVT2025-04-04
05055270979636RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979667RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986504RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979674RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986511RocketROCKET MEDICAL PLCNVT2023-10-24
05708265011179LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011841LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011186LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011858LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
04048438003497n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438003619n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004401n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004692n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438001080n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000762n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000823n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438006306n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
05708265010585LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
05708265010592LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
00815849020191Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020207Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020214Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022461Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020764Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020771Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020788Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022478Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09