Advance Serenity™ 14
GUDID 05391525785004
Advance Serenity 14 4mm x 2cm x 150cm
CREAGH MEDICAL LIMITED
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 05391525785004 |
| NIH Device Record Key | d81ffccb-c8bc-4f6c-bdd8-49be709c17aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advance Serenity™ 14 |
| Version Model Number | SER14-150-40-20 |
| Company DUNS | 985021909 |
| Company Name | CREAGH MEDICAL LIMITED |
| 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 |
Device Dimensions
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Balloon Length | 20 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391525785004 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171251
FDA Product Code
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
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 | 2020-04-13 |
| Device Publish Date | 2020-04-03 |
On-Brand Devices [Advance Serenity™ 14]
| 05391525785066 | Advance Serenity 14 4mm x 22cm x 150cm |
| 05391525785059 | Advance Serenity 14 4mm x 15cm x 150cm |
| 05391525785042 | Advance Serenity 14 4mm x 10cm x 150cm |
| 05391525785035 | Advance Serenity 14 4mm x 8cm x 150cm |
| 05391525785028 | Advance Serenity 14 4mm x 6cm x 150cm |
| 05391525785011 | Advance Serenity 14 4mm x 4cm x 150cm |
| 05391525785004 | Advance Serenity 14 4mm x 2cm x 150cm |
| 05391525784991 | Advance Serenity 14 3.5mm x 22cm x 150cm |
| 05391525784984 | Advance Serenity 14 3.5mm x 15cm x 150cm |
| 05391525784977 | Advance Serenity 14 3.5mm x 10cm x 150cm |
| 05391525784960 | Advance Serenity 14 3.5mm x 8cm x 150cm |
| 05391525784953 | Advance Serenity 14 3.5mm x 6cm x 150cm |
| 05391525784946 | Advance Serenity 14 3.5mm x 4cm x 150cm |
| 05391525784939 | Advance Serenity 14 3.5mm x 2cm x 150cm |
| 05391525784922 | Advance Serenity 14 3mm x 22cm x 150cm |
| 05391525784915 | Advance Serenity 14 3mm x 15cm x 150cm |
| 05391525784908 | Advance Serenity 14 3mm x 10cm x 150cm |
| 05391525784892 | Advance Serenity 14 3mm x 8cm x 150cm |
| 05391525784885 | Advance Serenity 14 3mm x 6cm x 150cm |
| 05391525784878 | Advance Serenity 14 3mm x 4cm x 150cm |
| 05391525784861 | Advance Serenity 14 3mm x 2cm x 150cm |
| 05391525784854 | Advance Serenity 14 2.5mm x 22cm x 150cm |
| 05391525784847 | Advance Serenity 14 2.5mm x 15cm x 150cm |
| 05391525784830 | Advance Serenity 14 2.5mm x 10cm x 150cm |
| 05391525784823 | Advance Serenity 14 2.5mm x 8cm x 150cm |
| 05391525784816 | Advance Serenity 14 2.5mm x 6cm x 150cm |
| 05391525784809 | Advance Serenity 14 2.5mm x 4cm x 150cm |
| 05391525784793 | Advance Serenity 14 2.5mm x 2cm x 150cm |
| 05391525784786 | Advance Serenity 14 2mm x 22cm x 150cm |
| 05391525784779 | Advance Serenity 14 2mm x 15cm x 150cm |
| 05391525784762 | Advance Serenity 14 2mm x 10cm x 150cm |
| 05391525784755 | Advance Serenity 14 2mm x 8cm x 150cm |
| 05391525784748 | Advance Serenity 14 2mm x 6cm x 150cm |
| 05391525784731 | Advance Serenity 14 2mm x 4cm x 150cm |
| 05391525784724 | Advance Serenity 14 2mm x 2cm x 150cm |
| 05391525784717 | Advance Serenity 14 4mm x 22cm x 120cm |
| 05391525784700 | Advance Serenity 14 4mm x 15cm x 120cm |
| 05391525784694 | Advance Serenity 14 4mm x 10cm x 120cm |
| 05391525784687 | Advance Serenity 14 4mm x 8cm x 120cm |
| 05391525784670 | Advance Serenity 14 4mm x 6cm x 120cm |
| 05391525784663 | Advance Serenity 14 4mm x 4cm x 120cm |
| 05391525784656 | Advance Serenity 14 4mm x 2cm x 120cm |
| 05391525784649 | Advance Serenity 14 3.5mm x 22cm x 120cm |
| 05391525784632 | Advance Serenity 14 3.5mm x 15cm x 120cm |
| 05391525784625 | Advance Serenity 14 3.5mm x 10cm x 120cm |
| 05391525784618 | Advance Serenity 14 3.5mm x 8cm x 120cm |
| 05391525784601 | Advance Serenity 14 3.5mm x 6cm x 120cm |
| 05391525784595 | Advance Serenity 14 3.5mm x 4cm x 120cm |
| 05391525784588 | Advance Serenity 14 3.5mm x 2cm x 120cm |
| 05391525784571 | Advance Serenity 14 3mm x 22cm x 120cm |
Trademark Results [Advance Serenity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVANCE SERENITY 88610774 not registered Live/Pending |
Cook Medical Technologies LLC 2019-09-10 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.