5P1 Transducer

GUDID 05704916000257

Cardiac Adult, Abdominal, Adult Cephalic (Transcranial)

Bk Medical ApS

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID05704916000257
NIH Device Record Key4ebe74b3-575a-45b2-b806-f608f56b3c8f
Commercial Distribution StatusIn Commercial Distribution
Brand Name5P1 Transducer
Version Model Number9077
Company DUNS310093901
Company NameBk Medical ApS
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105704916000257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-17

Devices Manufactured by Bk Medical ApS

05704916001711 - I13C3fx Transducer2023-06-22 Tracked Laparoscopic Intraoperative Transducer -with build-in tracking internal sensor
05704916001667 - Non-implantable needle guide, single-use2022-12-15 Disposable 18g Transperineal Needle Guide
05704916001698 - Non-implantable needle guide, single-use2022-12-15 Non-implantable needle guide, single-use
05704916001599 - Rob12C42022-05-31 The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted p
05704916000240 - I13C3f Transducer2020-04-03 Intraoperative
05704916001131 - N20P6 Transducer2020-04-03 High resolution, mini footprint, Intraoperative (neuro) imaging
05704916001315 - I12C5 transducer2020-04-03 Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)
05704916001407 - Non-implantable, needle guide, reusable2019-12-23 Reusable Transperineal Needle Guide

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