In.Pact™ 018
GUDID 00763000291303
DCB 018 IPU04015013P D4.0 L150 UL0130
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00763000291303 |
| NIH Device Record Key | c824b4da-78b7-452e-a254-ee2c964196ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | In.Pact™ 018 |
| Version Model Number | IPU04015013P |
| 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 | true |
| 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
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 150 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000291303 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140010
FDA Product Code
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-18 |
On-Brand Devices [In.Pact™ 018]
| 00763000291679 | DCB 018 IPU06015020P D6.0 L150 UL0200 |
| 00763000291662 | DCB 018 IPU06015013P D6.0 L150 UL0130 |
| 00763000291648 | DCB 018 IPU06012020P D6.0 L120 UL0200 |
| 00763000291631 | DCB 018 IPU06012013P D6.0 L120 UL0130 |
| 00763000291617 | DCB 018 IPU06010020P D6.0 L100 UL0200 |
| 00763000291600 | DCB 018 IPU06010013P D6.0 L100 UL0130 |
| 00763000291587 | DCB 018 IPU06008020P D6.0 L080 UL0200 |
| 00763000291570 | DCB 018 IPU06008013P D6.0 L080 UL0130 |
| 00763000291556 | DCB 018 IPU06006020P D6.0 L060 UL0200 |
| 00763000291549 | DCB 018 IPU06006013P D6.0 L060 UL0130 |
| 00763000291525 | DCB 018 IPU06004020P D6.0 L040 UL0200 |
| 00763000291518 | DCB 018 IPU06004013P D6.0 L040 UL0130 |
| 00763000291495 | DCB 018 IPU05015020P D5.0 L150 UL0200 |
| 00763000291488 | DCB 018 IPU05015013P D5.0 L150 UL0130 |
| 00763000291464 | DCB 018 IPU05012020P D5.0 L120 UL0200 |
| 00763000291457 | DCB 018 IPU05012013P D5.0 L120 UL0130 |
| 00763000291433 | DCB 018 IPU05010020P D5.0 L100 UL0200 |
| 00763000291426 | DCB 018 IPU05010013P D5.0 L100 UL0130 |
| 00763000291402 | DCB 018 IPU05008020P D5.0 L080 UL0200 |
| 00763000291396 | DCB 018 IPU05008013P D5.0 L080 UL0130 |
| 00763000291372 | DCB 018 IPU05006020P D5.0 L060 UL0200 |
| 00763000291365 | DCB 018 IPU05006013P D5.0 L060 UL0130 |
| 00763000291341 | DCB 018 IPU05004020P D5.0 L040 UL0200 |
| 00763000291334 | DCB 018 IPU05004013P D5.0 L040 UL0130 |
| 00763000291310 | DCB 018 IPU04015020P D4.0 L150 UL0200 |
| 00763000291303 | DCB 018 IPU04015013P D4.0 L150 UL0130 |
| 00763000291280 | DCB 018 IPU04012020P D4.0 L120 UL0200 |
| 00763000291273 | DCB 018 IPU04012013P D4.0 L120 UL0130 |
| 00763000291259 | DCB 018 IPU04010020P D4.0 L100 UL0200 |
| 00763000291242 | DCB 018 IPU04010013P D4.0 L100 UL0130 |
| 00763000291228 | DCB 018 IPU04008020P D4.0 L080 UL0200 |
| 00763000291211 | DCB 018 IPU04008013P D4.0 L080 UL0130 |
| 00763000291198 | DCB 018 IPU04006020P D4.0 L060 UL0200 |
| 00763000291181 | DCB 018 IPU04006013P D4.0 L060 UL0130 |
| 00763000291167 | DCB 018 IPU04004020P D4.0 L040 UL0200 |
| 00763000291150 | DCB 018 IPU04004013P D4.0 L040 UL0130 |
| 00763000291761 | DCB 018 IPU07008020P D7.0 L080 UL0200 |
| 00763000291754 | DCB 018 IPU07008013P D7.0 L080 UL0130 |
| 00763000291730 | DCB 018 IPU07006020P D7.0 L060 UL0200 |
| 00763000291723 | DCB 018 IPU07006013P D7.0 L060 UL0130 |
| 00763000291709 | DCB 018 IPU07004020P D7.0 L040 UL0200 |
| 00763000291693 | DCB 018 IPU07004013P D7.0 L040 UL0130 |
Trademark Results [In.Pact]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IN.PACT 79320694 not registered Live/Pending |
INVATEC Technology Center GmbH 2021-08-10 |
 IN.PACT 79074790 3864435 Dead/Cancelled |
INVATEC Technology Center GmbH 2009-06-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.