FDA.report

Mendaera Probe and Robot Drape Kit

Primary DI
00850062065086
Brand
Mendaera Probe and Robot Drape Kit
Company
Mendaera, Inc.
Model
K004-01
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions

SubmissionSupplement
K250524000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250524000Mendaera Guidance SystemMendaera, Inc.2025-07-02ITX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850062065083PackageGS15In Commercial Distribution
00850062065086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006206508310850062065083
00850062065086008500620650868500620650860850062065086

GMDN Terms

TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Sizes

TypeValueUnit
Length1778Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-877-636-3237support@mendaera.com

Regulatory Flags

DUNS number
100193165
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850062065000Focalist SystemC001-012025-08-11
10850062065021Mendaera Universal Instrument Guide Kit, LongK001-012025-08-11
00850062065031Focalist System Softwarerc252025-08-11
10850062065045Mendaera Universal Instrument Guide Kit, ShortK002-012025-08-11
10850062065069Mendaera Robot Drape KitK003-012025-08-11

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