DEVICE: UroMax Ultra Kit (08714729341383)
Device Identifier (DI) Information
UroMax Ultra Kit
M0062251310
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
M0062251310
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
Balloon Dilatation Catheter Kit
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 32022 | Urethral dilatation catheter, non-medicated |
A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KOE | DILATOR, URETHRAL |
| EZN | DILATOR, CATHETER, URETERAL |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 30 F Diameter |
| Device Size Text, specify: 8 cm Effective Length |
| Device Size Text, specify: 10 mm Diameter |
Device Record Status
b1f10d0a-c56b-4d3b-9a55-ce37d04cb8ce
August 12, 2019
4
September 24, 2016
August 12, 2019
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined