FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GlideLight™
DI: M2045003020
·
Model: 500-302
·
Spectranetics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GlideLight™
- Primary DI
- M2045003020
- Version / Model
- 500-302
- Catalog Number
- 500-302
- Company Name
- Spectranetics Corporation
- Labeler DUNS
- 151047370
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-19
- Public Version
- 5
- Public Version Date
- 2021-10-26
- Public Version Status
- Update
- Public Device Record Key
- 0bf80970-2fb9-43e1-8915-3320957c2a82
- Distribution End Date
- 2019-02-06
Device Description
GlideLight™ Laser Sheath
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MFA | Device, Removal, Pacemaker Electrode, Percutaneous | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M2045003020 | HIBCC |
Customer Contacts
- Phone
- 1-800-633-0960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.192 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit