UNITY TETRASPOT 8065000236

GUDID 10380650002362

25GA TETRASPOT MultiSpot Laser Probe

Alcon Laboratories, Inc.

Ophthalmic laser system beam guide
Primary Device ID10380650002362
NIH Device Record Key8e3ea273-e353-4e96-9f72-8b9135a61423
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNITY TETRASPOT
Version Model Number00380650002365
Catalog Number8065000236
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100380650002365 [Primary]
GS110380650002362 [Package]
Contains: 00380650002365
Package: Box [6 Units]
In Commercial Distribution

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-11
Device Publish Date2024-07-03

On-Brand Devices [UNITY TETRASPOT]

1038065000237927GA TETRASPOT MultiSpot Laser Probe
1038065000236225GA TETRASPOT MultiSpot Laser Probe

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