AccessGUDID - DEVICE: Solox (04035479049218)

GUDID

Device Identifier (DI) Information

Brand Name: Solox
Version or Model: SLX 58/13-BP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 333900
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479049218
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *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?
35223	Endocardial/interventricular septal pacing lead	An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTB	permanent pacemaker Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950037	024

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 41 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length: 58 cm
Device Size Text, specify: Distance tip-atrial dipole: 13 cm
Device Size Text, specify: Max. Diameter: 2.7 mm

Device Record Status

Public Device Record Key: 87d2515d-3ce5-4c36-9324-170f4fd04fb3
Public Version Date: March 20, 2024
Public Version Number: 6
DI Record Publish Date: August 21, 2014