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
| 07613327656763 - BPX | 2026-03-12 Pistol Battery |
| 07613327656770 - BPX | 2026-03-12 Pencil Battery |
| 07613327657760 - BPX | 2026-03-12 Sagittal Saw |
| 07613327657777 - BPX | 2026-03-12 Micro Drill |
| 07613327657784 - BPX | 2026-03-12 Oscillating Saw |
| 07613327657791 - BPX | 2026-03-12 Universal Driver |
| 07613327657807 - N/A | 2026-03-12 Handpiece Insert Tray - Top |
| 07613327657814 - BPX | 2026-03-12 Reciprocating Saw |
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 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.