FDA.reportPublic FDA data

OWL

Primary DI
00825114003064
Brand
OWL
Company
Diros Technology Inc
Model
D463-005
Catalog number
D463-005
Device description
OWL STERILE SINGLE USE DISPOSABLE GASSERIAN GANGLION RF INSULATED CANNULA (19GA), 105MM LONG, 5MM BARE TIP
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062758000OWL URF-3APDiros Technology, Inc.2006-09-27GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825114003064PackageGS110In Commercial Distribution
00825114001664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825114003064008251140030648251140030640825114003064
00825114001664008251140016648251140016640825114001664

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
00825114014862OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114014879OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114000032OWLURF-2AP553-1002023-06-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
20763000835631AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835648AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835655AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000296AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000302AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000326COOLIEF*Avanos Medical, Inc.GXI2022-03-12
00193493985920AVANOS*Avanos Medical, Inc.GXI2022-03-12
00191506013097SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013103SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013110SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013127SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000166AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000173AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000197AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000203AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478804AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478811AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478828AVANOSAvanos Medical, Inc.GXI2021-03-11