Reusable Vascular Access Bracket

GUDID 00841912104734

Vascular Access Bracket for Sonoscanner U-Lite Linear Probe

PROTEK MEDICAL PRODUCTS, INC.

Ultrasound imaging system tracking holder, reusable
Primary Device ID00841912104734
NIH Device Record Key3140b445-9843-41f6-a3f4-c23c7888b821
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Vascular Access Bracket
Version Model Number6261
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912104734 [Direct Marking]
GS110841912104731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


[00841912104734]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2017-01-31

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

10841912106049 - System Cover2024-07-25
10841912106490 - Sterile Protective Barrier Kit2024-07-25
10841912106506 - Sterile Protective Barrier Kit2024-07-25
10841912106513 - Sterile Protective Barrier Kit2024-07-25
10841912106520 - Sterile Protective Barrier Kit2024-07-25
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

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