DEVICE: ACE (00614950025589)
Device Identifier (DI) Information
ACE
34020
In Commercial Distribution
0034020
ACE SURGICAL SUPPLY CO., INC.
34020
In Commercial Distribution
0034020
ACE SURGICAL SUPPLY CO., INC.
ACE NEW GAUZE 1/4 X 5YDS PLAIN STR X-RAY DETECTABLE L/F 60/CA MSDS
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
48128 | Gauze strip, non-antimicrobial |
A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRL | FIBER, MEDICAL, ABSORBENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: No special storage conditions required |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d88ea1f8-7489-4fdf-8f26-411e41942ee7
December 20, 2022
3
October 16, 2019
December 20, 2022
3
October 16, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(508)588-3100
214
ritaknight@acesurgical.com
ritaknight@acesurgical.com