FDA.reportPublic FDA data

Matreneu® Percutaneous Balloon Compression Kit

Primary DI
06939698601463
Brand
Matreneu® Percutaneous Balloon Compression Kit
Company
Shenzhen Shineyard Medical Device Co.,Ltd.
Model
PBCS-125015
Catalog number
PBCS-125015
Device description
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220920000Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd.2022-09-07HAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06939698601463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06939698601463069396986014636939698601463

GMDN Terms#

Term, Definition table
TermDefinition
Neural-tissue balloon catheterA sterile, flexible tube with a balloon at the distal tip used for the compression or dilation of neural tissue under direct endoscopic or fluoroscopic vision. It is inserted percutaneously over a metal stylet and typically has a small (mini) diameter with an elongated or a double (figure of 8) balloon; it is made of plastic/silicone materials and may be supplied with the stylet. It is typically used to treat trigeminal neuralgia (controlled balloon compression of the trigeminal ganglion causes selected injury to the insulation on nerve fibres which relieves pain). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544919616
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939698601234Matreneu® Percutaneous Balloon Compression KitPBCS-083513PBCS-0835132023-06-07
06939698601241Matreneu® Percutaneous Balloon Compression KitPBCS-083514PBCS-0835142023-06-07
06939698601258Matreneu® Percutaneous Balloon Compression KitPBCS-083515PBCS-0835152023-06-07
06939698601265Matreneu® Percutaneous Balloon Compression KitPBCS-085013PBCS-0850132023-06-07
06939698601272Matreneu® Percutaneous Balloon Compression KitPBCS-085014PBCS-0850142023-06-07
06939698601289Matreneu® Percutaneous Balloon Compression KitPBCS-085015PBCS-0850152023-06-07
06939698601296Matreneu® Percutaneous Balloon Compression KitPBCS-088013PBCS-0880132023-06-07
06939698601302Matreneu® Percutaneous Balloon Compression KitPBCS-088014PBCS-0880142023-06-07
06939698601326Matreneu® Percutaneous Balloon Compression KitPBCS-103513PBCS-1035132023-06-07
06939698601333Matreneu® Percutaneous Balloon Compression KitPBCS-103514PBCS-1035142023-06-07
06939698601340Matreneu® Percutaneous Balloon Compression KitPBCS-103515PBCS-1035152023-06-07
06939698601357Matreneu® Percutaneous Balloon Compression KitPBCS-105013PBCS-1050132023-06-07
06939698601364Matreneu® Percutaneous Balloon Compression KitPBCS-105014PBCS-1050142023-06-07
06939698601388Matreneu® Percutaneous Balloon Compression KitPBCS-108013PBCS-1080132023-06-07
06939698601395Matreneu® Percutaneous Balloon Compression KitPBCS-108014PBCS-1080142023-06-07
06939698601401Matreneu® Percutaneous Balloon Compression KitPBCS-108015PBCS-1080152023-06-07
06939698601418Matreneu® Percutaneous Balloon Compression KitPBCS-123513PBCS-1235132023-06-07
06939698601425Matreneu® Percutaneous Balloon Compression KitPBCS-123514PBCS-1235142023-06-07
06939698601432Matreneu® Percutaneous Balloon Compression KitPBCS-123515PBCS-1235152023-06-07
06939698601449Matreneu® Percutaneous Balloon Compression KitPBCS-125013PBCS-1250132023-06-07

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