MK-500500

GUDID 30810003221958

MicroKeratome Blades, ACS/ALK. Each blade is laser inspected and calibrated. 10/bx

MICROSPECIALITIES, INC.

Keratome blade, single-use
Primary Device ID30810003221958
NIH Device Record Key04275804-aa8c-41c5-b934-c2d27b791d1a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMK-500500
Catalog NumberMK-500500
Company DUNS013469890
Company NameMICROSPECIALITIES, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx
Phone203-874-1832
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110810003221954 [Primary]
GS130810003221958 [Package]
Contains: 10810003221954
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HNOKeratome, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-12
Device Publish Date2019-01-03

Devices Manufactured by MICROSPECIALITIES, INC.

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30810003221064 - NA2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 20. Have the ultimate control of corneal flap thickness while
30810003221071 - NA2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 30. Have the ultimate control of corneal flap thickness while
30810003221088 - NA2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 40. Have the ultimate control of corneal flap thickness while
30810003221095 - NA2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, plus 10. Have the ultimate control of corneal flap thickness while
30810003221101 - NA2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, PLUS 20. Have the ultimate control of corneal flap thickness while
30810003221118 - NA2024-02-12 MicroKeratome Blades, Laser Calibrated XP, Plano. Have the ultimate control of corneal flap thickness while using a single head
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