Cryomatic 2.5mm Std Ret Pencil

GUDID 05055272707640

KEELER LIMITED

Ophthalmic cryosurgical system, electronic
Primary Device ID05055272707640
NIH Device Record Key21e1ed13-51c6-4c0d-964d-6706e96d855c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryomatic 2.5mm Std Ret Pencil
Version Model Number2509-P-8000
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
GS105055272707640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRNUnit, Cryophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055272707640]

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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