FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Quick-Cross™Select
DI: M2045180890
·
Model: 518-089
·
Spectranetics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Quick-Cross™Select
- Primary DI
- M2045180890
- Version / Model
- 518-089
- Catalog Number
- 518-089
- Company Name
- Spectranetics Corporation
- Labeler DUNS
- 151047370
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-26
- Public Version
- 9
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- e2635dbc-1a5d-40ba-a163-4e25935a9a18
- Distribution End Date
- 2019-02-06
Device Description
Quick-Cross™Select Support Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M2045180891 | HIBCC | Box | 5 | Not in Commercial Distribution | 2019-02-06 |
| Primary | M2045180890 | HIBCC |
Customer Contacts
- Phone
- 1-800-633-0960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 90 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit