FDA.reportPublic FDA data

LAM Fixation Carotid surgery

Primary DI
04260493311946
Brand
LAM Fixation Carotid surgery
Company
Compumedics Germany GmbH
Model
Fix_LAM_C_7556
Catalog number
7556
Device description
LAM Set Carotid surgery bilateral with 2 x 1 MHz probe, click&stay
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
04260493311946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260493311946042604933119464260493311946

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497731797690info@dwl.de
+1 888 757 5351info@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
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18