FDA.reportPublic FDA data

Temperature Sensor Probe, 18G x 20cm

Primary DI
10810563022329
Brand
Temperature Sensor Probe, 18G x 20cm
Company
ENDOCARE, INC.
Model
ABL-18TP20
Device description
Ablation accessory: disposable temperature probe, 18G/20cm Probe QTY 1
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEYSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240784000Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.2024-05-29NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810563022329PackageGS15In Commercial Distribution
00810563022322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081056302232910810563022329
00810563022322008105630223228105630223220810563022322

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, temperatureA small unit dedicated to the measurement and display of the patient's body temperature at one or more body sites. Signals are typically obtained through connected temperature probes, e.g., skin, rectal. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the body temperature information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
928955509
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810563022299IntelliBlate Ximitry Probe Assembly, 13G x 15cmIB-XPA-13152024-08-09
10810563022305IntelliBlate Ximitry Probe Assembly, 13G x 20cmIB-XPA-13202024-08-09
10810563022312IntelliBlate Ximitry Probe Assembly, 13G x 27cmIB-XPA-13272024-08-09

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