SlimFit Endocavity Probe Cover 2548

GUDID 10841912105318

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile
Primary Device ID10841912105318
NIH Device Record Key7916c0d9-d0a8-4f28-8ca5-73626e0d157d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimFit Endocavity Probe Cover
Version Model Number2548
Catalog Number2548
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
GS100841912105311 [Primary]
GS110841912105318 [Package]
Contains: 00841912105311
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 Number4
Public Version Date2018-07-06
Device Publish Date2017-11-03

On-Brand Devices [SlimFit Endocavity Probe Cover]

108419121053182548
108419121047792513

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