AccessGUDID - DEVICE: trophon2 Refurbished (09350855001037)

GUDID

Device Identifier (DI) Information

Brand Name: trophon2 Refurbished
Version or Model: N05000-1R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NANOSONICS LIMITED

Primary DI Number: 09350855001037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 741021943 *Terms of Use

Device Description: This is a refurbished trophon2

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):	No
Over the Counter (OTC):	Yes
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?
66554	Multiple clinical chemistry analyte electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential resulting from an enzymatic reaction, typically involving multiple immobilized enzymes, to determine the concentration of multiple clinical chemistry analytes (e.g., glucose, lactate) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173865	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: 1aba2705-3fd1-49a3-9eee-56fc9c8ecd82
Public Version Date: November 10, 2025
Public Version Number: 1
DI Record Publish Date: November 01, 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: 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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