Clear Image Singles Lite

GUDID 10856724004117

NEXT MEDICAL PRODUCTS, LLC

Skin topical coupling gel
Primary Device ID10856724004117
NIH Device Record Keya19ae93c-7df6-4366-8c51-7dad0698cbbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Image Singles Lite
Version Model Number06-100-030
Company DUNS078566628
Company NameNEXT MEDICAL PRODUCTS, LLC
Device Count100
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 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
GS110856724004117 [Unit of Use]
GS130856724004593 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

On-Brand Devices [Clear Image Singles Lite]

3085672400435706-050-030
3085672400413506-400-030
3085672400412806-400B-030
1085672400411706-100-030

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