Primary Device ID | 10858027006263 |
NIH Device Record Key | e47d5c3d-76a3-429c-a901-83c6df639603 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TearCare(R) Clearance Assistant - Sterile - 10 pk |
Version Model Number | FG 05642 |
Catalog Number | 5-104 |
Company DUNS | 962750381 |
Company Name | SIGHT SCIENCES, INC. |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858027006266 [Unit of Use] |
GS1 | 10858027006263 [Primary] |
HNR | Forceps, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-03-29 |
Device Publish Date | 2018-04-23 |
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00858027006266 - TearCare(R) Clearance Assistant - Sterile | 2023-08-04 Forceps - Sterile |
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00858027006501 - Sion Surgical Instrument | 2022-08-09 The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument. |
00858027006457 - TearCare System - TearCare SmartHub Kit | 2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter |
00858027006495 - TearCare System - TearCare SmartLids | 2022-03-11 Eyelid heat therapy system applicator |