AXS Offset DC050150A
GUDID 07613327361155
Delivery Assist Catheter
Stryker Corporation
Vascular guide-catheter, single-use| Primary Device ID | 07613327361155 |
| NIH Device Record Key | 64ed94d2-9976-4c71-a9cf-12282d80336e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AXS Offset |
| Version Model Number | M003DC050150A0 |
| Catalog Number | DC050150A |
| Company DUNS | 042405446 |
| Company Name | Stryker 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
Device Dimensions
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.05 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327361155 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163259
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2017-12-06 |
Devices Manufactured by Stryker Corporation
| 07613327419252 - Patient Helper | 2024-12-23 |
| 37613327556651 - Neptune | 2024-12-23 SafeAir 125mm Suction Sleeve, Non-Sterile |
| 07613327643879 - Iconix | 2024-12-19 Iconix DC Guide for 2.3mm Anchor |
| 07613327643886 - Iconix | 2024-12-19 Iconix DC Obturator for 2.3 Anchor |
| 07613327644067 - Neptune | 2024-12-16 V2 SPECIMEN COLLECTION MANIFOLD |
| 07613327262469 - VBOSS | 2024-12-10 ENDPLATE TIP SMALL |
| 07613327262483 - VBOSS | 2024-12-10 ENDPLATE TIP LARGE |
| 07613327262506 - VBOSS | 2024-12-10 ENDPLATE TIP OFFSET |
Trademark Results [AXS Offset]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXS OFFSET 87021393 5788129 Live/Registered |
Stryker Corporation 2016-05-02 |
AXS OFFSET 87021393 5788129 Live/Registered |
Stryker European Holdings I, LLC 2016-05-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.