MITEK SPORTS MEDICINE

GUDID 20815634020003

MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1

MICROMEDICS, INC.

Irrigation syringe
Primary Device ID20815634020003
NIH Device Record Key9ab53a69-a233-467a-ac1a-1aaf6d83abd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMITEK SPORTS MEDICINE
Version Model Number278011
Company DUNS066839630
Company NameMICROMEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815634020009 [Primary]
GS110815634020006 [Package]
Contains: 00815634020009
Package: Inner Pack [10 Units]
In Commercial Distribution
GS120815634020003 [Package]
Contains: 10815634020006
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

KYZSyringe, Irrigating (Non Dental)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


[20815634020003]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-18
Device Publish Date2019-01-16

On-Brand Devices [MITEK SPORTS MEDICINE]

20815634020041MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 18 CM
20815634020034MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 10 CM
00815634020023MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 5 CM
20815634020010MITEK SPORTS MEDICINE DUAL SPRAY TIP APPLICATOR TIP
20815634020003MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1

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