16 MHz probe, 2mm 3654

GUDID 04260493310468

16 MHz probe, 2.0 mm diameter

Compumedics Germany GmbH

Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe
Primary Device ID04260493310468
NIH Device Record Key3271cc3c-02ad-4bbc-b94c-b291577aa8e3
Commercial Distribution StatusIn Commercial Distribution
Brand Name16 MHz probe, 2mm
Version Model Number16 MHz_2
Catalog Number3654
Company DUNS344791632
Company NameCompumedics Germany GmbH
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de
Phone+497731797690
Emailinfo@dwl.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104260493310468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

[04260493310468]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-04

Devices Manufactured by Compumedics Germany GmbH

04260493312196 - DiaMon Fixation2023-07-04 DiaMon Set for handheld probes, bilateral with 2 x 2 MHz probes, handheld (2 meter cable)
04260493310901 - LAM Fixation Standard2020-12-17 LAM Set Standard WITHOUT probes, bilateral, screw topped
04260493310987 - LAM Fixation Mandibula2020-12-17 LAM Set Mandibula WITHOUT probes, bilateral, screw topped
04260493311007 - LAM Fixation Neurosurgery2020-12-17 LAM Set Neurosurgery WITHOUT probes, bilateral, screw topped
04260493311014 - LAM Fixation Carotid surgery2020-12-17 LAM Set Carotid surgery WITHOUT probes, bilateral, screw topped
04260493311045 - Headband Fixation L/XL2020-12-17 Headband Set WITHOUT probes, size L/XL, bilateral
04260493311052 - Headband Fixation L/XL2020-12-17 Headband Set size L/XL, unilateral with 2 MHz probe, screw topped
04260493311069 - Headband Fixation L/XL2020-12-17 Headband Set size L/XL, unilateral with 2 MHz probe, click&stay
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.