DEVICE: allSoft (00812261011813)
Device Identifier (DI) Information
allSoft
allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
In Commercial Distribution
MJO-5/70
ALLWIN MEDICAL DEVICES, INC.
allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
In Commercial Distribution
MJO-5/70
ALLWIN MEDICAL DEVICES, INC.
allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LJE | Catheter, Nephrostomy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K190659 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1db44c29-c61c-4429-bdc6-4913c97ccf39
January 17, 2024
1
January 09, 2024
January 17, 2024
1
January 09, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10812261011810 | 10 | 00812261011813 | In Commercial Distribution | Box Packing |
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
[?]
714-512-1709
info@allwinmedical.com
info@allwinmedical.com