Rocket

Primary DI
05055270934789
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R55990
Catalog number
R55990
Device description
Spinal Manometer Set - EA
Published
2017-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270934789PackageGS140In Commercial Distribution
05055270956187PackageGS12In Commercial Distribution
05055270913395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270934789050552709347895055270934789
05055270956187050552709561875055270956187
05055270913395050552709133955055270913395

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid manometer, mechanicalA sterile device designed to directly measure the cerebrospinal fluid (CSF) pressure in a patient. It is a mechanical instrument that connects with a dedicated hollow needle inserted into the subarachnoid (intrathecal) space of the lumbar section of the spinal column; CSF pressure is typically displayed on a dial showing readings in, e.g., cmH2O or mmH2O. Connectors, tubing, and the spinal needle are typically included. The device is intended to be used to determine variations in CSF pressure for the purposes of diagnosing, assessing trauma, or to evaluate some other clinical condition (e.g., tumours). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
544313588
Device count
1
DM exempt
true
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055270911643RocketR29662R296622023-11-03
05055270957245RocketR57616-16-00R57616-16-002023-11-03
05055270988188RocketR53086R530862023-11-03
05055270911612RocketR29658R296582023-10-31
05055270966155RocketR57422-VIPR57422-VIP2023-10-31
05055270974457RocketR57424-VIPR57424-VIP2023-10-31
05055270978868RocketR57603-00-90R57603-00-902023-10-31
05055270984296RocketR57525-00-T2R57525-00-T22023-10-31
05055270984524RocketR29656R296562023-10-31
05055270909060RocketR28135R281352023-10-30
05055270909329RocketR28410R284102023-10-30
05055270984463RocketR28406R284062023-10-30
05055270911575RocketR29654R296542023-10-24
05055270911582RocketR29655R296552023-10-24
05055270911629RocketR29660R296602023-10-24
05055270911636RocketR29661R296612023-10-24
05055270977137RocketR57008-00-FMR57008-00-FM2023-10-24
05055270977168RocketR57008-00-CNR57008-00-CN2023-10-24
05055270979322RocketR56215-MR56215-M2023-10-24
05055270979643RocketR57686R576862023-10-24