AccessGUDID - DEVICE: SureWave Elastography (00814848020775)

GUDID

Device Identifier (DI) Information

Brand Name: SureWave Elastography
Version or Model: Q7000225
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QUALITY ELECTRODYNAMICS LLC

Primary DI Number: 00814848020775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 614760119 *Terms of Use

Device Description: No description.

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):	No
Device labeled as "Not made with natural rubber latex":	No
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?
65288	Magnetic resonance elastography acoustic driver	An assembly of devices, consisting of an electrically-powered pneumatic wave generator and a noninvasive vibration applicator, intended for use with a magnetic resonance imaging (MRI) system to provide a measure of tissue elasticity/stiffness. The generator is used outside the MRI scanner room and is connected by pneumatic tubing to the applicator, which is applied to the site of interest on the patient’s body while within the MRI scanner. The pneumatically-transferred vibrations are applied to the body and MRI images are taken to facilitate evaluation/diagnosis of the condition of tissues (e.g. liver, brain), including damage and tumours.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242006	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 265fb940-f529-473c-8595-882535c668ae
Public Version Date: April 21, 2025
Public Version Number: 1
DI Record Publish Date: April 12, 2025

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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