AccessGUDID - DEVICE: MD Ophthalmic Dropper Bottles (00338779559222)

GUDID

Device Identifier (DI) Information

Brand Name: MD Ophthalmic Dropper Bottles
Version or Model: 5592-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5592-02
Company Name: Medisca Inc.

Primary DI Number: 00338779559222
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 794301960 *Terms of Use

Device Description: MD Ophthalmic Dropper Bottles, 15 mL, Sterile, Ready-to-fill, Clear with White Caps

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?
61338	Eye dropper bottle	A sterile device intended to store and dispense in drops an eye irrigation solution typically to flush the eye of irritating particulates/chemicals, or to treat a specific eye condition. It does not contain eye irrigation solution. It consists of a small bottle with a nozzle which acts as a dropper spout. 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: 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: 92d2f867-c9e5-4e20-8b76-01ce1e9a9d8e
Public Version Date: May 22, 2023
Public Version Number: 1
DI Record Publish Date: May 12, 2023