DEVICE: Ascerta™ Firm (08714729861720)
Device Identifier (DI) Information
						
						Ascerta™ Firm
						
M0061456410
In Commercial Distribution
						
						
						
BOSTON SCIENTIFIC CORPORATION
					
				M0061456410
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
						
						Ureteral Stent
					
				Device Characteristics
| MR Safe | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| 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? | 
|---|---|---|---|---|
| 58005 | Polymeric ureteral stent | 
													 
														A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.
											  		 
												 | 
												Active | true | 
FDA Product Code
[?]| Product Code | Product Code Name | 
|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC | 
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: 4.8 F Stent Diameter | 
| Device Size Text, specify: 24 cm Effective Length | 
| Device Size Text, specify: 1.6 mm Stent Diameter | 
Device Record Status
						
						d0942ed5-f7b1-4b74-a8d6-491c93fc22c4
						
March 29, 2018
2
September 24, 2015
					
				March 29, 2018
2
September 24, 2015
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