Sentrant™
GUDID 00643169792616
SHEATH SENSH2028W Sentrant Hydr EtO eIFU
MEDTRONIC, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 00643169792616 |
| NIH Device Record Key | d12162b7-37c1-47c1-8f8e-4b70f6cb66a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sentrant™ |
| Version Model Number | SENSH2028W |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 28 Centimeter |
| Length | 28 Centimeter |
| Length | 28 Centimeter |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
| Catheter Gauge | 20 French |
| Length | 28 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169792616 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171866
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-09-29 |
On-Brand Devices [Sentrant™]
| 00643169792722 | SHEATH SENSH2664W Sentrant Hydr EtO eIFU |
| 00643169792715 | SHEATH SENSH2464W Sentrant Hydr EtO eIFU |
| 00643169792708 | SHEATH SENSH2264W Sentrant Hydr EtO eIFU |
| 00643169792692 | SHEATH SENSH2064W Sentrant Hydr EtO eIFU |
| 00643169792685 | SHEATH SENSH1864W Sentrant Hydr EtO eIFU |
| 00643169792678 | SHEATH SENSH1664W Sentrant Hydr EtO eIFU |
| 00643169792661 | SHEATH SENSH1464W Sentrant Hydr EtO eIFU |
| 00643169792654 | SHEATH SENSH1264W Sentrant Hydr EtO eIFU |
| 00643169792647 | SHEATH SENSH2628W Sentrant Hydr EtO eIFU |
| 00643169792630 | SHEATH SENSH2428W Sentrant Hydr EtO eIFU |
| 00643169792623 | SHEATH SENSH2228W Sentrant Hydr EtO eIFU |
| 00643169792616 | SHEATH SENSH2028W Sentrant Hydr EtO eIFU |
| 00643169792609 | SHEATH SENSH1828W Sentrant Hydr EtO eIFU |
| 00643169792593 | SHEATH SENSH1628W Sentrant Hydr EtO eIFU |
| 00643169792586 | SHEATH SENSH1428W Sentrant Hydr EtO eIFU |
| 00643169792579 | SHEATH SENSH1228W Sentrant Hydr EtO eIFU |
| 00643169150379 | SHEATH SENSH2628W SENTRANT HYDRO |
| 00643169150362 | SHEATH SENSH2428W SENTRANT HYDRO |
| 00643169150355 | SHEATH SENSH2228W SENTRANT HYDRO |
| 00643169150348 | SHEATH SENSH2028W SENTRANT HYDRO |
| 00643169150331 | SHEATH SENSH1828W SENTRANT HYDRO |
| 00643169150324 | SHEATH SENSH1628W SENTRANT HYDRO |
| 00643169150317 | SHEATH SENSH1428W SENTRANT HYDRO |
| 00643169150300 | SHEATH SENSH1228W SENTRANT HYDRO |
| 00763000716462 | SENTRANT INTRODUCER SHEATH 26 FR X 28 CM |
| 00763000716455 | SENTRANT INTRODUCER SHEATH 24 FR X 28 CM |
| 00763000716448 | SENTRANT INTRODUCER SHEATH 22 FR X 28 CM |
| 00763000716431 | SENTRANT INTRODUCER SHEATH 20 FR X 28 CM |
| 00763000716424 | SENTRANT INTRODUCER SHEATH 18 FR X 28 CM |
| 00763000716417 | SENTRANT INTRODUCER SHEATH 16 FR X 28 CM |
| 00763000716400 | SENTRANT INTRODUCER SHEATH 14 FR X 28 CM |
| 00763000716394 | SENTRANT INTRODUCER SHEATH 12 FR X 28 CM |
| 00763000716387 | SENTRANT INTRODUCER SHEATH 26 FR X 64 CM |
| 00763000716370 | SENTRANT INTRODUCER SHEATH 24 FR X 64 CM |
| 00763000716363 | SENTRANT INTRODUCER SHEATH 22 FR X 64 CM |
| 00763000716356 | SENTRANT INTRODUCER SHEATH 20 FR X 64 CM |
| 00763000716349 | SENTRANT INTRODUCER SHEATH 18 FR X 64 CM |
| 00763000716332 | SENTRANT INTRODUCER SHEATH 16 FR X 64 CM |
| 00763000716325 | SENTRANT INTRODUCER SHEATH 14 FR X 64 CM |
| 00763000716318 | SENTRANT INTRODUCER SHEATH 12 FR X 64 CM |
| 00763000716301 | SENTRANT INTRODUCER SHEATH 26 FR X 28 CM |
| 00763000716295 | SENTRANT INTRODUCER SHEATH 24 FR X 28 CM |
| 00763000716288 | SENTRANT INTRODUCER SHEATH 22 FR X 28 CM |
| 00763000716271 | SENTRANT INTRODUCER SHEATH 20 FR X 28 CM |
| 00763000716264 | SENTRANT INTRODUCER SHEATH 18 FR X 28 CM |
| 00763000716257 | SENTRANT INTRODUCER SHEATH 16 FR X 28 CM |
| 00763000716240 | SENTRANT INTRODUCER SHEATH 14 FR X 28 CM |
| 00763000716233 | SENTRANT INTRODUCER SHEATH 12 FR X 28 CM |
Trademark Results [Sentrant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENTRANT 85443552 4675644 Live/Registered |
Medtronic Vascular, Inc. 2011-10-10 |
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