Rocket

Primary DI
05055270914231
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R57597
Catalog number
R57597
Device description
Rocket Trial Transfer Set - SOFT 18cm
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994327000EMBRYON TRANSFER CATHETERS/SETSRocket Medical Plc2000-02-28MQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270935625PackageGS110In Commercial Distribution
05055270957023PackageGS16In Commercial Distribution
05055270914231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270935625050552709356255055270935625
05055270957023050552709570235055270957023
05055270914231050552709142315055270914231

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction catheter setA collection of sterile devices used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure101 KiloPascal101 KiloPascal
Handling Environment Humidity1 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature-5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure101 KiloPascal101 KiloPascal
Storage Environment Humidity1 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4401914196988gudid@rocketmedical.com

Regulatory Flags#

DUNS number
544313588
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
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