DEVICE: CODMAN BACTISEAL (10886704041313)

Device Identifier (DI) Information

CODMAN BACTISEAL
82-3072
Not in Commercial Distribution
823072
Cerenovus, Inc.
10886704041313
GS1
September 01, 2022
1
607846297 *Terms of Use
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)
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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.
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
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FDA Product Code

[?]
Product Code Product Code Name
JXG Shunt, central nervous system and components
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102589 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6b8b904b-d951-4595-bc80-3cca3c984ca5
September 15, 2023
7
September 20, 2015
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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