Ultrasound Probe Cover Biopsy Needle Guide

GUDID 10848340013697

Disposable Probe Cover Accessories

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile
Primary Device ID10848340013697
NIH Device Record Keybffde8c8-36a5-4c6e-8c92-b18a7fd7e4a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound Probe Cover Biopsy Needle Guide
Version Model Number28-GG109
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340013690 [Primary]
GS110848340013697 [Package]
Contains: 00848340013690
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


[10848340013697]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

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10848340013703Disposable Probe Cover Accessories

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