AccessGUDID - DEVICE: TEARSCIENCE ACTIVATOR CLEAR (00810051250022)

GUDID

Device Identifier (DI) Information

Brand Name: TEARSCIENCE ACTIVATOR CLEAR
Version or Model: LFD-2100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0803-5001
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 00810051250022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010130626 *Terms of Use

Device Description: TS ACTIVATOR CLEAR, BOX OF 1, US

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?
58218	Eyelid thermal pulsation system applicator, single-use	An ophthalmic device designed to apply heat and pressure (intermittent pressure massage) to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It consists of two small plates, one positioned under the eyelid, and the other with heating/pulsing elements applied to the outside of the eyelid, and is used with a reusable control unit (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORZ	Eyelid thermal pulsation system

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
No Device Sizes

Device Record Status

Public Device Record Key: e83bb39e-8ee0-4a75-bab7-0091f5f33a40
Public Version Date: January 20, 2025
Public Version Number: 2
DI Record Publish Date: October 18, 2021