FDA.reportPublic FDA data

OWL

Primary DI
00825114000032
Brand
OWL
Company
Diros Technology Inc
Model
URF-2AP
Catalog number
553-100
Device description
OWL RadioFrequency RF Lesion Generator
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXDGenerator, Lesion, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021869000OWL RADIOFREQUENCY SYSTEM, MODEL URF-2APDiros Technology, Inc.2002-07-01GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825114000032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825114000032008251140000328251140000320825114000032

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-415-3440RBAKER@DIROSTECH.COM

Regulatory Flags#

DUNS number
202738675
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00825114014862OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114014879OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114001664OWLD463-005D463-0052016-09-01
00825114001732OWLD467-005-TCD467-005-TC2016-09-23
00825114001862OWL467-022/54/4467-022/54/42016-09-01
00825114001879OWL467-022/54/5-BC467-022/54/5-BC2016-09-01
00825114001886OWL467-022/100/5467-022/100/52016-09-01
00825114001893OWL467-022/100/5-BC467-022/100/5-BC2016-09-01
00825114001909OWL467-022/100/10-SC467-022/100/10-SC2016-09-01
00825114001930OWL466-018/100/5-SC466-018/100/5-SC2016-09-01
00825114001947OWL466-018/100/5-BC466-018/100/5-BC2016-09-01
00825114001954OWL466-018/100/10-SC466-018/100/10-SC2016-09-01
00825114001961OWL466-018/100/10-BC466-018/100/10-BC2016-09-01
00825114001978OWL466-018/150/10-SC466-018/150/10-SC2016-09-01
00825114001985OWL466-018/150/10-BC466-018/150/10-BC2016-09-01
00825114001992OWL467-022/100/10467-022/100/102016-09-01
00825114002005OWL467-022/100/2-SC467-022/100/2-SC2016-09-01
00825114002029OWL467-022/50/5-SC467-022/50/5-SC2016-09-01
00825114002050OWLDHC-022/50/5DHC-022/50/52016-09-01
00825114002067OWLDHC-022/50/5-SCDHC-022/50/5-SC2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
05415067049650NAST. JUDE MEDICAL, INC.GXD2024-03-26
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008504OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
10195327563424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
40195327563425Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
05415067034519N/AST. JUDE MEDICAL, INC.GXD2023-10-25
15415067034516N/AST. JUDE MEDICAL, INC.GXD2023-10-25
00852454006288RelievantRelievant Medsystems, Inc.GXD2022-12-09
00193493000692COOLIEF* Quad Pump Connector CableAvanos Medical, Inc.GXD2022-10-17
00193493000340AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000357AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000401AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493000418AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493473021COOLIEF* Basic-R GeneratorAvanos Medical, Inc.GXD2021-01-27
00193493473038COOLIEF* Cooled RF Advanced-R GeneratorAvanos Medical, Inc.GXD2021-01-27
05415067029317IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-14
05415067033833IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-11
00193493473014COOLIEF* Cooled RF Advanced GeneratorAvanos Medical, Inc.GXD2020-10-16