AccessGUDID - DEVICE: TearCare(R) Clearance Assistant PLUS (00858027006389)

GUDID

Device Identifier (DI) Information

Brand Name: TearCare(R) Clearance Assistant PLUS
Version or Model: FG 06950
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-107
Company Name: Sight Sciences, Inc.

Primary DI Number: 00858027006389
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962750381 *Terms of Use

Device Description: TearCare Clearance Assistant PLUS

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?
64301	Ophthalmic curette, single-use	A hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a single-use device.	Active	false
62673	Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-use	A sterile, hand-held manual surgical instrument designed to facilitate grasping, manipulation or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design, with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNS	Expressor
HNZ	Curette, Ophthalmic

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: 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: 80e3bda0-8ef2-44ef-aa0d-a3d9e16ec826
Public Version Date: August 30, 2023
Public Version Number: 1
DI Record Publish Date: August 22, 2023