AccessGUDID - DEVICE: LLD E Lead Locking Device (00813132023058)

GUDID

Device Identifier (DI) Information

Brand Name: LLD E Lead Locking Device
Version or Model: 518-039
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 518-039
Company Name: Spectranetics Corporation

Primary DI Number: 00813132023058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: No description.

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?
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
DRB	Stylet, Catheter

FDA Premarket Submission

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

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: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.012 Inch

Device Record Status

Public Device Record Key: 8b24ebcd-0282-49a5-9aa9-f2cfd8a35b94
Public Version Date: July 23, 2024
Public Version Number: 7
DI Record Publish Date: September 01, 2015