FDA.report

Halo Medical Technologies

Primary DI
00860008657367
Brand
Halo Medical Technologies
Company
Halo Medical Technologies, LLC
Model
HMT-EVG
Device description
Endovaginal Probe 2D
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions

SubmissionSupplement
K140899000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K140899000HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEMHalo Medical Technologies, LLC2014-05-05IYO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860008657367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008657367008600086573678600086573670860008657367

GMDN Terms

TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
065084024
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860008657305Halo Medical TechnologiesHMT-AIOSYS2023-09-29
00860008657312Halo Medical TechnologiesHMT-LTSYS2023-09-29
00860008657329Halo Medical TechnologiesHMT-TRP2023-09-29
00860008657336Halo Medical TechnologiesHMT-TRP 3D2023-09-29
00860008657343Halo Medical TechnologiesHMT-MCP2023-09-29
00860008657350Halo Medical TechnologiesHMT-MCP 3D2023-09-29
00860008657374Halo Medical TechnologiesHMT-EVG 3D2023-09-29
00860008657381Halo Medical TechnologiesHMT-SURM2023-09-29
00860008657886Halo Med. TechnologiesHMT MCP2023-09-29

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