FDA.reportPublic FDA data

16 MHz Adapter

Primary DI
04260493313254
Brand
16 MHz Adapter
Company
Compumedics Germany GmbH
Model
Ad_16 MHz_6999
Catalog number
6999
Device description
16 MHz adapter, yellow
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051085000DOPPLER-BOXCompumedics Germany Gmgh2005-05-05IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260493313254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260493313254042604933132544260493313254

GMDN Terms#

Term, Definition table
TermDefinition
Invasive vascular ultrasound system probeA hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888 757 5351info@dwl.de
+497731797690info@dwl.de

Regulatory Flags#

DUNS number
344791632
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260493312196DiaMon FixationFIx_DiaMon_789478942023-06-26
04260493310901LAM Fixation StandardFix_LAM_S_380638062020-12-09
04260493310987LAM Fixation MandibulaFix_LAM_M_399339932020-12-09
04260493311007LAM Fixation NeurosurgeryFix_LAM_N_399739972020-12-09
04260493311014LAM Fixation Carotid surgeryFix_LAM_C_399839982020-12-09
04260493311045Headband Fixation L/XLFix_Headband_L-XL_403840382020-12-09
04260493311052Headband Fixation L/XLFix_Headband_L-XL_403940392020-12-09
04260493311069Headband Fixation L/XLFix_Headband_L-XL_404040402020-12-09
04260493311076Headband Fixation L/XLFix_Headband_L-XL_404140412020-12-09
04260493311083Headband Fixation L/XLFix_Headband_L-XL_404240422020-12-09
04260493311137Headband Fixation XS/S/MFix_Headband_XS-S-M_553855382020-12-09
04260493311151Headband Fixation XS/S/MFix_Headband_XS-S-M_554055402020-12-09
04260493311175Headband Fixation XS/S/MFix_Headband_XS-S-M_554255422020-12-09
04260493311199Headband Fixation XS/S/MFix_Headband_XS-S-M_554455442020-12-09
04260493311205Headband Fixation XS/S/MFix_Headband_XS-S-M_554555452020-12-09
04260493311212LAM FixationFix_LAM_590559052020-12-09
04260493311243Headband Fixation XS/S/MFix_Headband_XS-S-M_678767872020-12-09
04260493311403LAM Fixation NeurosurgeryFix_LAM_N_686168612020-12-09
04260493311410LAM Fixation NeurosurgeryFix_LAM_N_686368632020-12-09
04260493311427LAM Fixation NeurosurgeryFix_LAM_N_686568652020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
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00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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