AccessGUDID - DEVICE: Epsila EV™ (00763000369743)

GUDID

Device Identifier (DI) Information

Brand Name: Epsila EV™
Version or Model: EAZ201
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000369743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: TOOL EAZ201 TUNNELING ZONE 2

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?
60956	Pacing/defibrillation lead tunneller	A sterile hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It is a long, thin, semi-flexible rod with a rounded distal tip and a handle at the proximal end to allow the surgeon to push through body tissues; it may include an integrated sheath (e.g., split sheath) intended to assist lead placement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWS	Implantable cardioverter defibrillator (non-CRT)
NVY	Permanent defibrillator electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220012	000
P220012	044

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
Handling Environment Temperature: between -31 and 136 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c57f666-0d84-455e-984e-c77a7b6455fb
Public Version Date: May 28, 2025
Public Version Number: 2
DI Record Publish Date: November 03, 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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