AccessGUDID - DEVICE: SLS™II (M2045000130)

GUDID

Device Identifier (DI) Information

Brand Name: SLS™II
Version or Model: 500-013
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 500-013
Company Name: Spectranetics Corporation

Primary DI Number: M2045000130
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: SLS™II Laser Sheath

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:	Yes
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?
45161	Pacing lead extraction kit, single-use	A collection of sterile devices designed to remove the electrically-conducting leads of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), typically in cases where infection has developed or a device malfunction has occurred. It typically includes stylets, dilating sheaths, snares, and retrieval baskets. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MFA	Device, Removal, Pacemaker Electrode, Percutaneous

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.225 Inch

Device Record Status

Public Device Record Key: 49cb8168-4d89-4aed-9b74-f6e3ebb73f2f
Public Version Date: October 26, 2021
Public Version Number: 5
DI Record Publish Date: August 19, 2014