AccessGUDID - DEVICE: .8mm Silicone Punctal Plug (00848782023875)

GUDID

Device Identifier (DI) Information

Brand Name: .8mm Silicone Punctal Plug
Version or Model: PPLUG8
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Surgical Specialties México, S. de R.L. de C.V.

Primary DI Number: 00848782023875
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 812762226 *Terms of Use

Device Description: .8mm Silicone Punctal Plug

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 [?]
Premarket Submission Number Not Available/Not Released

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: 899db625-d5c5-4022-b669-21fc0a44e1b0
Public Version Date: November 11, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2016