AccessGUDID - DEVICE: Trophon EPR (09350855000009)

GUDID

Device Identifier (DI) Information

Brand Name: Trophon EPR
Version or Model: N00010-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NANOSONICS LIMITED

Primary DI Number: 09350855000009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 741021943 *Terms of Use

Device Description: Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)

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?
66654	Atomized-chemical device disinfector	An electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet (e.g., with internal shelves) intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103059	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: f43cd76d-2012-4b2b-9b9b-6240056e9531
Public Version Date: June 06, 2024
Public Version Number: 9
DI Record Publish Date: September 21, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
09350855000108	1	09350855000009		In Commercial Distribution

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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