FDA.report

Mendaera Universal Instrument Guide Kit, Short

Primary DI
10850062065045
Brand
Mendaera Universal Instrument Guide Kit, Short
Company
Mendaera, Inc.
Model
K002-01
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
10850062065045PackageGS15In Commercial Distribution
00850062065048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006206504510850062065045
00850062065048008500620650488500620650480850062065048

GMDN Terms

TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Device Sizes

TypeValueUnit
Length165Millimeter

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
10850062065069Mendaera Robot Drape KitK003-012025-08-11
00850062065086Mendaera Probe and Robot Drape KitK004-012025-08-11

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