DEVICE: Axiom® (M665101263H0)
Device Identifier (DI) Information
Axiom®
101263H
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
101263H
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
Penrose Tubing, Silicone, With Holes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
43437 | Surgical capillary wound drain, luminal, synthetic polymer |
A sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K781749 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 0.625 Inch |
Length: 12 Inch |
Device Record Status
4cec87cd-a2bf-48dd-a4f5-1c91a3e30f03
July 06, 2018
4
September 23, 2016
July 06, 2018
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M665101263H3 | 10 | M665101263H1 | In Commercial Distribution | Case | |
M665101263H1 | 10 | M665101263H0 | 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