AccessGUDID - DEVICE: neodisher Mielclear (04029577140724)

GUDID

Device Identifier (DI) Information

Brand Name: neodisher Mielclear
Version or Model: 4029577140724
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Chemische Fabrik Dr. Weigert GmbH & Co. KG

Primary DI Number: 04029577140724
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 316788397 *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:	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?
58061	Instrument rinsing agent	A liquid substance with a neutral or acidic pH intended for the rinsing of medical/surgical instruments (e.g., specula, forceps) after machine cleaning and prior to full sterilization. It is typically a phosphoric acid (H3PO4) in an aqueous solution that neutralizes the alkaline residues from detergents and water (acidic rinse), or lubricants and drying activators (neutral rinse) and may be added, as specified by the manufacturer, to an automated washer. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLG	Cleaner, Ultrasonic, Medical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 859a0f10-e17e-48e1-8d45-57cb2a8a7a9f
Public Version Date: January 17, 2022
Public Version Number: 2
DI Record Publish Date: August 16, 2020