Nautica
GUDID 00836462002272
105-5094-153 NAUTICA MICROCATHETER
Micro Therapeutics, Inc.
Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use| Primary Device ID | 00836462002272 |
| NIH Device Record Key | 971e828f-454b-4400-bfde-b839e369321c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nautica |
| Version Model Number | 105-5094-153 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, 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 | false |
| Expiration Date | false |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836462002272 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093750
FDA Product Code
| KRA | Catheter, continuous flush |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-03-25 |
| Device Publish Date | 2015-10-09 |
Devices Manufactured by Micro Therapeutics, Inc.
| 00847536036215 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-250-10 V03 VANTAGE |
| 00847536036222 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-250-12 V03 VANTAGE |
| 00847536036239 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-250-14 V03 VANTAGE |
| 00847536036246 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-250-16 V03 VANTAGE |
| 00847536036253 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-250-18 V03 VANTAGE |
| 00847536036260 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-250-20 V03 VANTAGE |
| 00847536036277 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-275-10 V03 VANTAGE |
| 00847536036284 - PipelineTM Vantage Embolization Device with Shield TechnologyTM | 2024-01-08 STENT PED3-021-275-12 V03 VANTAGE |
Trademark Results [Nautica]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAUTICA 98278141 not registered Live/Pending |
Nautica Apparel, Inc. 2023-11-20 |
 NAUTICA 97920753 not registered Live/Pending |
Nautica Apparel Inc. 2023-05-04 |
 NAUTICA 97853809 not registered Live/Pending |
Nautica Apparel Inc. 2023-03-23 |
 NAUTICA 97853802 not registered Live/Pending |
Nautica Apparel Inc. 2023-03-23 |
 NAUTICA 97601115 not registered Live/Pending |
Nautica Apparel, Inc. 2022-09-21 |
 NAUTICA 97336388 not registered Live/Pending |
Nautica Apparel, Inc. 2022-03-29 |
 NAUTICA 97165014 not registered Live/Pending |
Nautica Apparel, Inc. 2021-12-09 |
 NAUTICA 97095101 not registered Live/Pending |
Nautica Apparel, Inc. 2021-10-27 |
 NAUTICA 90902015 not registered Live/Pending |
Nautica Apparel, Inc. 2021-08-25 |
 NAUTICA 90754372 not registered Live/Pending |
Nautica Apparel, Inc. 2021-06-04 |
 NAUTICA 90493963 not registered Live/Pending |
Nautica Apparel, Inc. 2021-01-28 |
 NAUTICA 90493956 not registered Live/Pending |
Nautica Apparel, Inc. 2021-01-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.