FDA.report

OWL

Primary DI
00825114004580
Brand
OWL
Company
Diros Technology Inc
Model
DTR-020/100/10
Catalog number
DTR-020/100/10
Device description
OWL STERILE SINGLE USE DISPOSABLE TRIDENT RF INSULATED CANNULA, 20GA, 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

Related Records

Contact Domains

Product Codes

CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications

CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00825114004580PackageGS110In Commercial Distribution
00825114004573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00825114004580008251140045808251140045800825114004580
00825114004573008251140045738251140045730825114004573

GMDN Terms

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

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

Contacts

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

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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

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