1.5mm Curved Cataract Pencil

GUDID 05055272707688

KEELER LIMITED

Ophthalmic cryosurgical system, electronic
Primary Device ID05055272707688
NIH Device Record Key5b66216d-576e-4de0-b4b0-f614e47eecb0
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5mm Curved Cataract Pencil
Version Model Number2509-P-8004
Company DUNS210164398
Company NameKEELER LIMITED
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055272707688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRNUnit, Cryophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055272707688]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-16

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05055272719674 - 532nm LIO2021-07-28
05055272720328 - 514/810nm LIO2021-07-28
05055272720380 - 577nm LIO2021-07-28
05055272719926 - 3.6V PROFESSIONAL OPHTH IN CASE2020-03-06

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