Nanostim™ LSN18501
GUDID 05415067027535
18F Nanostim Introducer, 50cm
ST. JUDE MEDICAL, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 05415067027535 |
| NIH Device Record Key | 361c131d-d785-428d-a5dc-e05c911c5a43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nanostim™ |
| Version Model Number | Introducer Kit |
| Catalog Number | LSN18501 |
| Company DUNS | 790268031 |
| Company Name | ST. JUDE MEDICAL, INC. |
| 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 | true |
| 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(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 19.7 Inch |
| Length | 50 Centimeter |
| Catheter Gauge | 18 French |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067027535 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161102
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
[05415067027535]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-03-21 |
On-Brand Devices [Nanostim™]
| 05415067027535 | 18F Nanostim Introducer, 50cm |
| 05414734509374 | 18F Nanostim Introducer, 30cm |
Trademark Results [Nanostim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NANOSTIM 86966952 5130469 Live/Registered |
Pacesetter, Inc. 2016-04-06 |
 NANOSTIM 85870426 4544638 Live/Registered |
Pacesetter, Inc. 2013-03-07 |
 NANOSTIM 85462588 4352401 Live/Registered |
NORTHERN INNOVATIONS HOLDING CORP. 2011-11-02 |
 NANOSTIM 77208146 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2007-06-18 |
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