Ultrasound Transducer Cover Kit 2222DM

GUDID 10841912100337

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile
Primary Device ID10841912100337
NIH Device Record Key791f965d-12ab-4e3f-9057-08580c5d54c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound Transducer Cover Kit
Version Model Number2222
Catalog Number2222DM
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912100330 [Primary]
GS110841912100337 [Package]
Contains: 00841912100330
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-16

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