AccessGUDID - DEVICE: Vega (08031527019826)

GUDID

Device Identifier (DI) Information

Brand Name: Vega
Version or Model: RLK41U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RLK41U
Company Name: MICROPORT CRM SRL

Primary DI Number: 08031527019826
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438860859 *Terms of Use

Device Description: VEGA Stylet Kit 52cm

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?
46717	Pacing/defibrillation lead stylet	A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130010	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: less than 25 Degrees Celsius
Special Storage Condition, Specify: Excursion permitted to 0-50°C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1b87487-22a7-480f-a763-c08bfa16d028
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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