AccessGUDID - DEVICE: Comfortear™ (10810003223552)

GUDID

Device Identifier (DI) Information

Brand Name: Comfortear™
Version or Model: 24-2007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24-2007
Company Name: MICROSPECIALITIES, INC.

Primary DI Number: 10810003223552
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013469890 *Terms of Use

Device Description: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Medium, 0.8mm.

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):	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?
36237	Lacrimal punctum plug	A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZU	Plug, Punctum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050851	000

Device Exempt from Premarket Submission: No 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
Outer Diameter: 0.8 Millimeter

Device Record Status

Public Device Record Key: dff70444-5704-4617-ac19-40af66ada8d0
Public Version Date: January 13, 2025
Public Version Number: 3
DI Record Publish Date: January 03, 2019