AccessGUDID - DEVICE: Lacrimal punctum plug (03760087120561)

GUDID

Device Identifier (DI) Information

Brand Name: Lacrimal punctum plug
Version or Model: PRE-LOADED PVP PERFORATED PLUG J.A. BERNARD, M.D.
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S1.3512u
Company Name: FCI S A S FCI 20 22

Primary DI Number: 03760087120561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 763408366 *Terms of Use

Device Description: A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.

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: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.9 Millimeter

Device Record Status

Public Device Record Key: 81a43c00-4c11-48c0-92aa-3e974d7b570a
Public Version Date: March 04, 2020
Public Version Number: 1
DI Record Publish Date: February 25, 2020