AccessGUDID - DEVICE: ClosureRFS™ (00763000723293)

GUDID

Device Identifier (DI) Information

Brand Name: ClosureRFS™
Version or Model: RFS2-6-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000723293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: STYLET RFS2-6-12 CLOSUREFAST

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
62232	Peripheral vascular radio-frequency ablation catheter	A sterile, rigid, hand-held luminal device intended to be percutaneously introduced into the peripheral vasculature as the distal component of a radio-frequency ablation system, to deliver radio-frequency current, in a bipolar configuration, for ablation of venous tissue to treat venous reflux disease (varicose veins). It typically includes an inner trocar/stylet to assist introduction and is maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052003	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
Special Storage Condition, Specify: Store the device in a dry area away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Maximum electrode diameter: 6 Fr
Length: 12.0 Centimeter

Device Record Status

Public Device Record Key: 1ec809b6-f276-430b-878b-6457b45d4696
Public Version Date: May 27, 2024
Public Version Number: 1
DI Record Publish Date: May 19, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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