AccessGUDID - DEVICE: OWL (00825114004009)

GUDID

Device Identifier (DI) Information

Brand Name: OWL
Version or Model: 467-022/50/4-SC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 467-022/50/4-SC
Company Name: Diros Technology Inc

Primary DI Number: 00825114004009
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 SHARP CURVED RF INSULATED CANNULA (22 Ga.), 50 mm LONG, 4 mm BARE TIP

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?
58739	Percutaneous radio-frequency ablation probe cannula, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXI	Probe, Radiofrequency Lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102566	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: a27b10bc-5391-4b83-a478-ac38035fa266
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: September 01, 2016