DEVICE: Total Abscession (H787140008010)
Device Identifier (DI) Information
Total Abscession
14000801
In Commercial Distribution
ANGIODYNAMICS, INC.
14000801
In Commercial Distribution
ANGIODYNAMICS, INC.
6.5F x 15cm Total Abscession General Drainage Catheter (Locking Pigtail)
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? |
---|---|---|---|---|
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBX | CATHETER, IRRIGATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 15 Centimeter |
Catheter Gauge: 6.5 French |
Device Record Status
aeff5b12-65e9-41e5-9356-62afd66d799a
March 08, 2022
4
September 16, 2015
March 08, 2022
4
September 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
H787140008015 | 5 | H787140008010 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
GS1 | 15051684011402 |
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
[?]
+1(518)795-1676
dgreer@angiodynamics.com
dgreer@angiodynamics.com