Quick-Access™ 519-001
GUDID M204519001AA0
Quick-Access™ Needle Holder
Spectranetics Corporation
Interventional radiology percutaneous-access procedure kit| Primary Device ID | M204519001AA0 |
| NIH Device Record Key | a0656901-33d7-44ab-a1dc-041ceef6b37f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quick-Access™ |
| Version Model Number | 519-001AA |
| Catalog Number | 519-001 |
| 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 | |
| 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020729 [Primary] |
| HIBCC | M204519001AA0 [Secondary] |
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 |
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
Ethylene Oxide
[M204519001AA0]
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 [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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