AccessGUDID - DEVICE: FORM FIT® Hydrogel Canalicular Plug (00845819000274)

GUDID

Device Identifier (DI) Information

Brand Name: FORM FIT® Hydrogel Canalicular Plug
Version or Model: 6303, 6303-T, B-6303
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OASIS MEDICAL, INC.

Primary DI Number: 00845819000274
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194121018 *Terms of Use

Device Description: Form Fit® Hydrogel Canalicular Plug in Squeeze Inserter

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: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: b286fdb4-feb5-494c-b549-b24547fbe30b
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: June 30, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10845819000271	10	00845819000274	In Commercial Distribution	Carton
20845819000278	2	00845819000274	In Commercial Distribution	Carton
30845819000275	100	00845819000274	In Commercial Distribution	Plastic Bag