AccessGUDID - DEVICE: NOU-CLEAN SPRAY (ENOU19849)

GUDID

Device Identifier (DI) Information

Brand Name: NOU-CLEAN SPRAY
Version or Model: 1984
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nouvag AG

Primary DI Number: ENOU19849
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480610476 *Terms of Use

Device Description: Cleaning spray for Instruments and Motors 500ml

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):	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?
15772	Surgical instrument maintenance lubricant	A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFD	Dermatome
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
GEY	Motor, Surgical Instrument, Ac-Powered
HBC	Motor, Drill, Electric
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental
DZI	Drill, Bone, Powered

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: 3b2510ed-c38e-4fdf-98b0-80c8ef9c9470
Public Version Date: September 17, 2018
Public Version Number: 1
DI Record Publish Date: August 15, 2018

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

Customer Contact

[?]

Phone: +41718466600
Email: info@nouvag.com

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