AccessGUDID - DEVICE: OWL (00825114001756)

GUDID

Device Identifier (DI) Information

Brand Name: OWL
Version or Model: D466-015-TC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D466-015-TC
Company Name: Diros Technology Inc

Primary DI Number: 00825114001756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202738675 *Terms of Use

Device Description: OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 15 CM CANNULA (THERMOCOUPLE)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61931	Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use	A hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXI	Probe, Radiofrequency Lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110593	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9763e140-e54b-41f4-b406-ff1cacc36eec
Public Version Date: May 03, 2023
Public Version Number: 7
DI Record Publish Date: September 01, 2016