AccessGUDID - DEVICE: NA (00721902015946)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: EP003997S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00721902015946
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: NEEDLE EP003997S BROCKEN 56CM STER 10L

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?
47248	Cardiac transseptal needle, single-use	A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRC	Trocar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 -34 and 57 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 56.0 Centimeter
Outer Diameter: 0.912 Millimeter

Device Record Status

Public Device Record Key: 03e49aa7-04e3-47b5-b159-57aa21632d6d
Public Version Date: August 20, 2020
Public Version Number: 4
DI Record Publish Date: April 23, 2016

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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