FDA.reportPublic FDA data

OWL

Primary DI
00825114002197
Brand
OWL
Company
Diros Technology Inc
Model
DHC-022/54/4
Catalog number
DHC-022/54/4
Device description
OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 54mm LONG, 4mm BARE TIP
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K102566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102566000OWL CANNULAEDiros Technology, Inc.2011-06-03GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825114007758PackageGS110In Commercial Distribution
00825114002197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825114007758008251140077588251140077580825114007758
00825114002197008251140021978251140021970825114002197

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe cannula, single-useA rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (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

Contacts#

Phone, Email table
PhoneEmail
9054153440RBAKER@DIROSTECH.COM

Regulatory Flags#

DUNS number
202738675
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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