Non-Sterile Endocavity Probe Cover Kit 2202

GUDID 20841912103311

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile
Primary Device ID20841912103311
NIH Device Record Key5d8bbc87-fe25-465f-b5f5-0b6ba07bbfc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNon-Sterile Endocavity Probe Cover Kit
Version Model Number2202
Catalog Number2202
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count10
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912103317 [Unit of Use]
GS120841912103311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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