Non-Sterile Latex Endocavity Probe Cover 3242

GUDID 20841912104073

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile
Primary Device ID20841912104073
NIH Device Record Keya6d09402-a021-44ea-ab49-ba7e13988792
Commercial Distribution StatusIn Commercial Distribution
Brand NameNon-Sterile Latex Endocavity Probe Cover
Version Model Number3242
Catalog Number3242
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count500
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912104079 [Unit of Use]
GS120841912104073 [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

On-Brand Devices [Non-Sterile Latex Endocavity Probe Cover]

008419121043215030
408419121009253244
308419121009283241
208419121040733242
208419121009213240

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