DEVICE: Axiom® Petite® CWV (M6652030)
Device Identifier (DI) Information
Axiom® Petite® CWV
203
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
203
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
Closed Wound Drainage Kit, Petite®, Silicone, With Vacuum Tubes and Tube Holder
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBX | Catheter, Irrigation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K965146 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 7 FR |
Total Volume: 10 Milliliter |
Device Record Status
f3b2ef51-07be-4f1a-adad-76c51efb1a46
March 08, 2022
2
September 23, 2018
March 08, 2022
2
September 23, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M6652033 | 0 | M6652031 | In Commercial Distribution | Case | |
M6652031 | 10 | M6652030 | In Commercial Distribution | Box |
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
[?]
310-533-9020
Sales@AxiomMed.com
Sales@AxiomMed.com