Non-Sterile Probe Storage Covers

GUDID 40841912104268

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile
Primary Device ID40841912104268
NIH Device Record Key12f08e22-414d-4437-94a4-85fc978d2387
Commercial Distribution StatusIn Commercial Distribution
Brand NameNon-Sterile Probe Storage Covers
Version Model Number1160
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count100
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912104260 [Unit of Use]
GS130841912104261 [Primary]
GS140841912104268 [Package]
Contains: 30841912104261
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMPCover, Barrier, Protective

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 Date2016-10-10

On-Brand Devices [Non-Sterile Probe Storage Covers]

408419121042681160
608419121042621160
808419121042661160

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.