AccessGUDID - DEVICE: SLS II Laser Sheath (00813132020309)

GUDID

Device Identifier (DI) Information

Brand Name: SLS II Laser Sheath
Version or Model: 500-012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500-012
Company Name: Spectranetics Corporation

Primary DI Number: 00813132020309
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:	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: 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: 0.192 Inch
Length: 50 Centimeter

Device Record Status

Public Device Record Key: e4c1908a-5f2f-46ab-9901-31958ed8564b
Public Version Date: August 21, 2024
Public Version Number: 7
DI Record Publish Date: February 06, 2015