FDA UDI
In Commercial Distribution
🇺🇸 United States
TightRail™
DI: M204545513AA0
·
Model: 545-513AA
·
Spectranetics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TightRail™
- Primary DI
- M204545513AA0
- Version / Model
- 545-513AA
- Catalog Number
- 545-513
- Company Name
- Spectranetics Corporation
- Labeler DUNS
- 151047370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-12
- Public Version
- 3
- Public Version Date
- 2021-10-26
- Public Version Status
- Update
- Public Device Record Key
- 7877d415-9f89-4eb7-b1e5-cd000bf623ff
Device Description
TightRail™ Rotating Dilator 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 |
|---|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | 870.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38128 | Vascular dilator, single-use | A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M204545513AA0 | HIBCC |
Customer Contacts
- Phone
- 1-800-633-0960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 0.171 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry