DEVICE: Harrison (00827002167667)
Device Identifier (DI) Information
Harrison
G16766
In Commercial Distribution
J-HFBS-503540
COOK INCORPORATED
G16766
In Commercial Distribution
J-HFBS-503540
COOK INCORPORATED
Harrison Fetal Bladder Stent Set
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
62396 | Foetal bladder shunt |
A sterile non-bioabsorbable tubular device intended to be implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract by providing a temporary drainage route for urine from the bladder into the amniotic sac, until the defect can be surgically repaired after birth. It is made of synthetic polymer materials and is typically designed with retention features (e.g., double pigtail). It is inserted through the maternal abdominal wall via a percutaneous suprapubic access tract, under ultrasound guidance; disposable devices to assist implantation are typically included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MPR | Stent,bladder,fetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in dark, dry, cool place. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7b160f94-c413-4e11-9b10-3b9d30b4530e
March 29, 2018
2
September 24, 2014
March 29, 2018
2
September 24, 2014
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 |
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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
[?]
+1(812)330-5494
sharedservices@cookmedical.com
sharedservices@cookmedical.com