DEVICE: ACE (00614950000029)
Device Identifier (DI) Information
ACE
0033138
In Commercial Distribution
0033138
ACE SURGICAL SUPPLY CO., INC.
0033138
In Commercial Distribution
0033138
ACE SURGICAL SUPPLY CO., INC.
DRAPE ACE POWER UNIT 24X24" STER L/F 5/PKG
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? |
---|---|---|---|---|
58975 | Instrument/equipment drape, reusable, sterile |
A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a reusable device intended to be sanitized between each use.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KKX | Drape, surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 24 Inch |
Length: 24 Inch |
Device Record Status
414f8874-e16a-4f89-bef9-c51ee46909a2
March 29, 2018
2
October 21, 2015
March 29, 2018
2
October 21, 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 |
---|---|---|---|---|---|
10614950000026 | 5 | 00614950000029 | In Commercial Distribution | Tyvec Bag |
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