Director XT Multi Gauge Needle Guide 4500

GUDID 10841912104373

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use
Primary Device ID10841912104373
NIH Device Record Keya7f0dce0-e24d-4ead-9af8-0e7018e78f99
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirector XT Multi Gauge Needle Guide
Version Model Number4500
Catalog Number4500
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912104376 [Primary]
GS110841912104373 [Package]
Contains: 00841912104376
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2016-09-16

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

00841912106691 - Reusable Biopsy Bracket2022-06-10 Reusable Biopsy Bracket for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
00841912106745 - Biopsy Starter Kit2022-06-10 Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
10841912107107 - Sterile Disposable Endocavity Needle Guide2022-04-11 Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers
10841912107084 - Sterile Single-Use Probe Cover Kit2022-03-21
10841912107091 - Sterile Single-Use Surgical Probe Cover Kit2022-03-21
00841912107049 - Reusable Biopsy Bracket2021-12-27 Biospy Bracket for Zonare L10-5 Ultrasound Transducers
10841912107053 - General Purpose Probe Cover2021-12-27
00841912107070 - Biopsy Starter Kit2021-12-27 Biopsy Starter Kit for Zonare L10-5 Ultrasound Transducers
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.