AccessGUDID - DEVICE: Phoenix Neuro (03760124133738)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix Neuro
Version or Model: RA11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SOPHYSA

Primary DI Number: 03760124133738
Issuing Agency: GS1
Commercial Distribution End Date: May 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 262951353 *Terms of Use

Device Description: Perf. Catheter Reservoir, Large dome, AB, 11 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
65412	Cerebrospinal fluid shunt port/reservoir	An implantable component of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt designed to be connected to a lumbar, ventricular and/or peritoneal catheter (not included) to permit hypodermic infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the central nervous system via the subarachnoid lumbar or cerebral space, in the management of raised cerebrospinal fluid (CSF) pressure (e.g., caused by hydrocephalus); it may also be used for drainage of CSF. It consists of a plastic puncturable dome with catheter connections; it does not include a valve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021644	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96ac0f1b-494b-427a-aee3-b6e423ab2c34
Public Version Date: May 18, 2023
Public Version Number: 4
DI Record Publish Date: October 16, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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