DEVICE: Axiom® Petite® CWV (M6652020)

Device Identifier (DI) Information

Axiom® Petite® CWV
202
In Commercial Distribution

AXIOM MEDICAL, INCORPORATED
M6652020
HIBCC

1
094439676 *Terms of Use
Closed Wound Drainage Kit, Petite®, Silicone, With Vacuum Tubes and Tube Holder
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
11305 Closed-wound drain, non-bioabsorbable
A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GBX Catheter, Irrigation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K965146 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 11 FR
Total Volume: 10 Milliliter
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Device Record Status

9ab7ba3e-a4cf-4edb-bbb8-d1236be29119
March 08, 2022
2
September 23, 2018
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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
M6652023 10 M6652021 In Commercial Distribution Case
M6652021 10 M6652020 In Commercial Distribution Box
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Secondary DI

[?]
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

[?]
310-533-9020
Sales@AxiomMed.com
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