DEVICE: CODMAN BACTISEAL (10886704041313)
Device Identifier (DI) Information
CODMAN BACTISEAL
82-3072
Not in Commercial Distribution
823072
Cerenovus, Inc.
82-3072
Not in Commercial Distribution
823072
Cerenovus, Inc.
CODMAN BACTISEAL Ventricular Catheter and Distal Catheter Kit with BACTISEAL Shunt System Contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Stylet (1), RA Adapter (1), Information Manual (1)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61159 | Peritoneal/atrial cerebrospinal fluid catheter |
A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.
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Active | true |
61376 | Intracerebral infusion/drainage catheter, long-term |
A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JXG | Shunt, central nervous system and components |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K102589 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit |
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit |
Storage Environment Temperature: between 2 and 27 Degrees Celsius |
Handling Environment Temperature: between 2 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6b8b904b-d951-4595-bc80-3cca3c984ca5
September 15, 2023
7
September 20, 2015
September 15, 2023
7
September 20, 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 |
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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(800)255-2500
xx@xx.xx
xx@xx.xx