AccessGUDID - DEVICE: Nanodropper B14 (00860003576120)

GUDID

Device Identifier (DI) Information

Brand Name: Nanodropper B14
Version or Model: B14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LUNA-B14
Company Name: NANODROPPER, INC.

Primary DI Number: 00860003576120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081371550 *Terms of Use

Device Description: The Nanodropper B14 is an eye drop bottle adaptor. The Nanodropper B14 is for single-bottle use only.

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?
64886	Eye dropper bottle nozzle adaptor	A nozzle extension intended to be fitted to an eye dropper bottle to decrease the droplet size of an eye irrigation/treatment solution during self-administration. It is intended to be used for the expected duration of the content of a single bottle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYX	Dispenser, Liquid Medication

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 489c3a41-6369-4848-9e61-3860277f8479
Public Version Date: October 30, 2024
Public Version Number: 1
DI Record Publish Date: October 22, 2024