AccessGUDID - DEVICE: Symplicity Spyral™ (00763000354466)

GUDID

Device Identifier (DI) Information

Brand Name: Symplicity Spyral™
Version or Model: RDN016
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000354466
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: SPYRAL CATHETER RDN016 US COMMERCIAL

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):	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?
58893	Renal denervation radio-frequency ablation catheter	A sterile, steerable, thin, flexible tube containing one or more monopolar electrodes intended to be introduced percutaneously into the renal artery to transmit precisely-focused, low-level, radio-frequency (RF) current, from a connected RF generator, to disrupt renal nerves for therapeutic denervation of the kidney; commonly known as renal denervation (RDN). The device has embedded metallic electrodes and may be available in a variety of forms (e.g., deflectable tip, balloon catheter). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QYI	Ablation catheter, renal denervation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220026	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 -35 and 57 Degrees Celsius
Storage Environment Atmospheric Pressure: between 30 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric Pressure: between 595 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.78 MM Minimum Inner Diameter
Device Size Text, specify: 1.32 MM Outer Diameter
Device Size Text, specify: 117 CM Effective Length
Device Size Text, specify: 19 MM Tip Diameter
Device Size Text, specify: 6 FR Guide Catheter
Device Size Text, specify: 0.36 MM Maximum Guidewire Diameter

Device Record Status

Public Device Record Key: 002038bf-d386-4268-85de-9e6ce3a12fb5
Public Version Date: December 08, 2023
Public Version Number: 1
DI Record Publish Date: November 30, 2023

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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