UNITY TETRASPOT 8065000237

GUDID 10380650002379

27GA TETRASPOT MultiSpot Laser Probe

Alcon Laboratories, Inc.

Ophthalmic laser system beam guide
Primary Device ID10380650002379
NIH Device Record Key0cc08ea7-8de6-4408-b7f1-cf4cb49f26fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNITY TETRASPOT
Version Model Number00380650002372
Catalog Number8065000237
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100380650002372 [Primary]
GS110380650002379 [Package]
Contains: 00380650002372
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.