GlideLight™ 500-301
GUDID M204500301AA0
GlideLight™ Laser Sheath
Spectranetics Corporation
Pacing lead extraction kit, single-use| Primary Device ID | M204500301AA0 |
| NIH Device Record Key | bf0a392b-6993-43a1-8ae0-3b3d9a54a156 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GlideLight™ |
| Version Model Number | 500-301AA |
| Catalog Number | 500-301 |
| 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 |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
| Outer Diameter | 0.164 Inch |
| Length | 50 Centimeter |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020323 [Primary] |
| HIBCC | M204500301AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P960042
FDA Product Code
| MFA | Device, Removal, Pacemaker Electrode, Percutaneous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
[M204500301AA0]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-02-06 |
On-Brand Devices [GlideLight™]
| M204500303AA0 | GlideLight™ Laser Sheath |
| M204500302AA0 | GlideLight™ Laser Sheath |
| M204500301AA0 | GlideLight™ Laser Sheath |
| M2045003030 | GlideLight™ Laser Sheath |
| M2045003020 | GlideLight™ Laser Sheath |
| M2045003010 | GlideLight™ Laser Sheath |
Trademark Results [GlideLight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLIDELIGHT 85433970 4243271 Live/Registered |
The Spectranetics Corporation 2011-09-28 |
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