Quick-Access™ 519-005
GUDID M2045190051
Quick-Access™ Needle Holder
Spectranetics Corporation
Interventional radiology percutaneous-access procedure kit| Primary Device ID | M2045190051 |
| NIH Device Record Key | 1439cc38-559a-4af3-a017-5287d44cf4f7 |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Quick-Access™ |
| Version Model Number | 519-005 |
| Catalog Number | 519-005 |
| 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 | false |
| 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
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| www.complaints@spnc.com |
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 |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M2045190050 [Primary] |
| HIBCC | M2045190051 [Package] Contains: M2045190050 Package: Box [5 Units] Discontinued: 2019-02-06 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112887
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
[M2045190051]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2014-08-26 |
On-Brand Devices [Quick-Access™]
| 00813132020736 | Quick-Access™ Needle Holder |
| M204519001AA0 | Quick-Access™ Needle Holder |
| M2045190051 | Quick-Access™ Needle Holder |
| M2045190010 | Quick-Access™ Needle Holder |
Trademark Results [Quick-Access]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUICK-ACCESS 85824086 4522960 Live/Registered |
The Spectranetics Corporation 2013-01-15 |
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