| Primary Device ID | M204500013AA0 |
| NIH Device Record Key | 1cd507d9-f32a-465a-982e-3c1289e3bf5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SLS™II |
| Version Model Number | 500-013AA |
| Catalog Number | 500-013 |
| Company DUNS | 151047370 |
| Company Name | Spectranetics Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.225 Inch |
| Length | 50 Centimeter |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020316 [Primary] |
| HIBCC | M204500013AA0 [Secondary] |
| MFA | Device, Removal, Pacemaker Electrode, Percutaneous |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
[M204500013AA0]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-02-06 |
| M204500013AA0 | SLS™II Laser Sheath |
| M204500012AA0 | SLS™II Laser Sheath |
| M204500001AA0 | SLS™II Laser Sheath |
| M2045000130 | SLS™II Laser Sheath |
| M2045000120 | SLS™II Laser Sheath |
| M2045000010 | SLS™II Laser Sheath |