Rocket

Primary DI
05055270935328
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R57508
Catalog number
R57508
Device description
Rocket Cervical Mucus Sampling Syringe
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055270935328PackageGS125In Commercial Distribution
05055270956729PackageGS18In Commercial Distribution
05055270913937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055270935328050552709353285055270935328
05055270956729050552709567295055270956729
05055270913937050552709139375055270913937

GMDN Terms

TermDefinition
Intrauterine cannula, single-useA sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge6French
Length20Centimeter

Storage And Handling

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

Sterilization Methods

Method

Contacts

PhoneEmail
+4401914196988gudid@rocketmedical.com

Regulatory Flags

DUNS number
544313588
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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

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05055270977168RocketR57008-00-CNR57008-00-CN2023-10-24
05055270979322RocketR56215-MR56215-M2023-10-24
05055270979643RocketR57686R576862023-10-24