18L5s Transducer

GUDID 05704916000394

Musculoskeletal, Small Organ (Small Parts), Peripheral Vessel (Peripheral Vascular), Pediatric

Bk Medical ApS

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID05704916000394
NIH Device Record Key5a4797a8-d396-4a25-9032-b72979342579
Commercial Distribution StatusIn Commercial Distribution
Brand Name18L5s Transducer
Version Model Number9081
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
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
GS105704916000394 [Primary]

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 Number3
Public Version Date2018-05-23
Device Publish Date2016-11-14

Devices Manufactured by Bk Medical ApS

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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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