AccessGUDID - DEVICE: StrataVarius (00763000292553)

GUDID

Device Identifier (DI) Information

Brand Name: StrataVarius
Version or Model: 45809
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC PS MEDICAL, INC.

Primary DI Number: 00763000292553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089055867 *Terms of Use

Device Description: TOOL 45809 STRATAVARIUS ADJUSTMENT

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
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?
44856	Cerebrospinal fluid shunt valve programmer	A device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It typically includes electronic circuits, a control panel, a programming information display, and transmitter/identification devices (e.g., smart cards). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041992	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f31a71b5-7de9-4e57-81b3-4a80bb5096bb
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 25, 2023

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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