Non-Sterile Probe Cover Kit 2255

GUDID 10841912104175

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile
Primary Device ID10841912104175
NIH Device Record Key194ebd3e-c378-4927-b610-a8d76d34b3d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNon-Sterile Probe Cover Kit
Version Model Number2255
Catalog Number2255
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 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
GS100841912104178 [Primary]
GS110841912104175 [Package]
Contains: 00841912104178
Package: [50 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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