FDA.reportPublic FDA data

OWL

Primary DI
00825114004665
Brand
OWL
Company
Diros Technology Inc
Model
DTR-018/100/10
Catalog number
DTR-018/100/10
Device description
OWL STERILE SINGLE USE DISPOSABLE TRIDENT RF INSULATED CANNULA, 18GA, 10MM BARE TIP FOR 10CM PROBE
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825114004665PackageGS110In Commercial Distribution
00825114004658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825114004665008251140046658251140046650825114004665
00825114004658008251140046588251140046580825114004658

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system probe cannula, single-useA sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during RF ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9054153440RBAKER@DIROSTECH.COM

Regulatory Flags#

DUNS number
202738675
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
00825114014879OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114000032OWLURF-2AP553-1002023-06-19
00825114001770OWLD467-005-TCD467-005-TC2016-09-23
00825114007031OWLDHC-020/50/5DHC-020/50/52016-09-01
00825114003842OWL467-022/50/5467-022/50/52016-09-01
00825114006478OWLDHC-016/150/6DHC-016/150/62016-09-01
00825114008526OWL466-020/54/10-SC466-020/54/10-SC2016-10-03
00825114000018OWLURF-3AP653-1002016-09-01
00825114000025OWLMLA-4653-100-MLA2016-09-23
00825114000421OWL653-447653-4472016-09-23
825114001770OWLD467-005-TCD467-005-TC2016-09-23
00825114001749OWLD467-010-TCD467-010-TC2016-09-01
00825114001756OWLD466-015-TCD466-015-TC2016-09-01
00825114001763OWLD466-020-TCD466-020-TC2016-09-01
00825114006249OWLD466-005D466-0052016-09-01
00825114006256OWLD467-005-TCHD467-005-TCH2016-09-01
00825114006263OWLD466-010D466-0102016-09-01
00825114006270OWLD467-010-TCHD467-010-TCH2016-09-01
00825114006287OWLD466-0152016-09-01
00825114006294OWLD466-015-TCHD466-015-TCH2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14895233602366LCCSLCCS Products LimitedGXI2025-11-17
00856895008153One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-09-01
00856895008139One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00856895008146One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00852454006424IntraceptRelievant Medsystems, Inc.GXI2025-08-04
00825114014879OWLDiros Technology IncGXI2025-07-16
04048223131947RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223131954RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132005RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132340TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132357TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132470RFTL SonoPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132647RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132692RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132715RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223049709RGNPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050132RFTLPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050484RFTL SonoPajunk GmbH MedizintechnologieGXI2025-01-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
40195327666355Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SCV181505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201515Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV221005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18