FDA.reportPublic FDA data

SLS™II

Primary DI
M204500012AA0
Brand
SLS™II
Company
Spectranetics Corporation
Model
500-012AA
Catalog number
500-012
Device description
SLS™II Laser Sheath
Published
2015-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MFADevice, Removal, Pacemaker Electrode, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFADevice, Removal, Pacemaker Electrode, PercutaneousUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960042002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960042002SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATHSpectranetics (Philips)1997-12-09MFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813132020309PrimaryGS10
M204500012AA0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132020309008131320203098131320203090813132020309

GMDN Terms#

Term, Definition table
TermDefinition
Pacing lead extraction kit, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Centimeter
Outer Diameter0.192Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-800-633-0960complaints@spnc.com
1-800-633-0960SPNC-complaints@philips.com
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
151047370
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132020293SLS II Laser Sheath500-001500-0012015-02-06
00813132020309SLS II Laser Sheath500-012500-0122015-02-06
00813132020316SLS II Laser Sheath500-013500-0132015-02-06
00813132020903SightRail Manual Dilator Sheath550-008550-0082015-02-06
00813132020910SightRail Manual Dilator Sheath550-010550-0102015-02-06
00813132020927SightRail Manual Dilator Sheath550-011550-0112015-02-06
00813132020934SightRail Manual Dilator Sheath550-013550-0132015-02-06
00813132020941SightRail Manual Dilator Sheath555-508555-5082015-02-06
00813132020958SightRail Manual Dilator Sheath555-510555-5102015-02-06
00813132020965SightRail Manual Dilator Sheath555-511555-5112015-02-06
00813132020972SightRail Manual Dilator Sheath555-513555-5132015-02-06
00813132020002ELCA™110-001AA110-0012015-02-06
00813132020019ELCA™110-002AA110-0022015-02-06
00813132020026ELCA™110-003AA110-0032015-02-06
00813132020064ELCA™117-205AA117-2052015-02-06
00813132020071ELCA™120-008AA120-0082015-02-06
00813132025410ELCA™120-008AB120-0082017-12-04
00813132025427ELCA™117-205AB117-2052017-12-04
00813132025465ELCA™110-003AB110-0032017-12-04
00813132025472ELCA Coronary Laser Atherectomy Catheter110-002110-0022017-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813132020293SLS II Laser SheathSpectranetics CorporationMFA2015-02-06
00813132020309SLS II Laser SheathSpectranetics CorporationMFA2015-02-06
00813132020316SLS II Laser SheathSpectranetics CorporationMFA2015-02-06
00813132020323GlideLight Laser SheathSpectranetics CorporationMFA2015-02-06
00813132020330GlideLight Laser SheathSpectranetics CorporationMFA2015-02-06
00813132020347GlideLight Laser SheathSpectranetics CorporationMFA2015-02-06
M204500001AA0SLS™IISpectranetics CorporationMFA2015-02-06
M204500013AA0SLS™IISpectranetics CorporationMFA2015-02-06
M204500301AA0GlideLight™Spectranetics CorporationMFA2015-02-06
M204500302AA0GlideLight™Spectranetics CorporationMFA2015-02-06
M204500303AA0GlideLight™Spectranetics CorporationMFA2015-02-06
M2045000010SLS™IISpectranetics CorporationMFA2014-08-19
M2045000120SLS™IISpectranetics CorporationMFA2014-08-19
M2045000130SLS™IISpectranetics CorporationMFA2014-08-19
M2045003010GlideLight™Spectranetics CorporationMFA2014-08-19
M2045003020GlideLight™Spectranetics CorporationMFA2014-08-19
M2045003030GlideLight™Spectranetics CorporationMFA2014-08-19