Surgical Probe Cover Kit 1946

GUDID 10841912106537

PROTEK MEDICAL PRODUCTS, INC.

Intraoperative ultrasound imaging transducer cover
Primary Device ID10841912106537
NIH Device Record Key290467bc-60fa-433f-a4c6-8b898a630bf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical Probe Cover Kit
Version Model Number1946
Catalog Number1946
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
GS100841912106530 [Primary]
GS110841912106537 [Package]
Contains: 00841912106530
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 Number2
Public Version Date2021-05-18
Device Publish Date2020-06-01

On-Brand Devices [Surgical Probe Cover Kit]

108419121047551237
108419121040211934
108419121008321934
108419121008251933
108419121008181931
108419121008011930
108419121007951930
108419121007881930
108419121007711929
108419121065371946

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