EsoFLIP
GUDID 05391530810043
EsoFLIP Dilation Catheter for use with EndoFLIP System
CROSPON LIMITED
Gastrointestinal/biliary dilation balloon catheter| Primary Device ID | 05391530810043 |
| NIH Device Record Key | 6f9e84bf-0dc1-4844-8dc9-7039110a7399 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EsoFLIP |
| Version Model Number | ES-330 |
| Company DUNS | 989779517 |
| Company Name | CROSPON 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 |
Customer Support Contacts
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com | |
| Phone | 8552767766 |
| info@crospon.com |
Device Dimensions
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391530810043 [Primary] |
| GS1 | 05391530810098 [Package] Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132337
FDA Product Code
| PIE | Esophageal Dilator With Balloon And Electrode Sensors |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-02 |
On-Brand Devices [EsoFLIP]
| 05391530810043 | EsoFLIP Dilation Catheter for use with EndoFLIP System |
| 05391530810036 | EsoFLIP Dilation Catheter for use with EndoFLIP System |
| 05391530810159 | EsoFLIP Dilation Catheter for use with EndoFLIP System |
Trademark Results [EsoFLIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESOFLIP 77540759 3671897 Live/Registered |
Flip Technologies Limited 2008-08-06 |
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