AccessGUDID - DEVICE: Matreneu® Percutaneous Balloon Compression Kit (06939698601258)

GUDID

Device Identifier (DI) Information

Brand Name: Matreneu® Percutaneous Balloon Compression Kit
Version or Model: PBCS-083515
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PBCS-083515
Company Name: Shenzhen Shineyard Medical Device Co.,Ltd.

Primary DI Number: 06939698601258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544919616 *Terms of Use

Device Description: This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47157	Neural-tissue balloon catheter	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	Instrument, Surgical, Non-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220920	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Humidity: less than 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: babcd574-3eae-4d37-a3ae-126129fd5442
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023