DEVICE: Axiom® Sump-n-Sheath® Atraum® With ClotStop® (M665111155AT0)
Device Identifier (DI) Information
Axiom® Sump-n-Sheath® Atraum® With ClotStop®
111155AT
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
111155AT
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
Sump-n-Sheath®, Sump Drain, Three Lumens, Silicone, Large Eye, With Silicone Penrose, With Suture Ring, With ClotStop®
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? |
---|---|---|---|---|
15270 | Sump drain |
A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBS | Catheter, Ventricular, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K883887 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 0.625 Inch |
Length: 14 Inch |
Lumen/Inner Diameter: 9 Millimeter |
Device Record Status
c40b7975-d964-4251-a826-fec5ff8b9f9e
October 24, 2018
1
September 23, 2018
October 24, 2018
1
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 |
---|---|---|---|---|---|
M665111155AT3 | 10 | M665111155AT1 | In Commercial Distribution | Case | |
M665111155AT1 | 10 | M665111155AT0 | 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