AccessGUDID - DEVICE: DROPPER BOTTLE SYSTEM (00810080611818)

GUDID

Device Identifier (DI) Information

Brand Name: DROPPER BOTTLE SYSTEM
Version or Model: TE15-415-50-BOT-15BR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MPS Pharma & Medical, Inc.

Primary DI Number: 00810080611818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117970217 *Terms of Use

Device Description: TE 15ML BS DROPPER BOTTLE, NATURAL

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 0057de41-b557-4474-814b-3a2d6222cee3
Public Version Date: September 27, 2024
Public Version Number: 1
DI Record Publish Date: September 19, 2024