Flexi-Feel Probe Cover

GUDID 10848340014564

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use
Primary Device ID10848340014564
NIH Device Record Key26e5cc2c-e10e-4d87-8803-bf2acd1fad4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexi-Feel Probe Cover
Version Model NumberFF696NS
Company DUNS130785884
Company NameADVANCE MEDICAL DESIGNS, INC.
Device Count1
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340014567 [Primary]
GS110848340014564 [Package]
Contains: 00848340014567
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-31
Device Publish Date2023-05-23

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