DEVICE: ACE (00614950000029)

Device Identifier (DI) Information

ACE
0033138
In Commercial Distribution
0033138
ACE SURGICAL SUPPLY CO., INC.
00614950000029
GS1

1
042763706 *Terms of Use
DRAPE ACE POWER UNIT 24X24" STER L/F 5/PKG
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KKX Drape, surgical
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Width: 24 Inch
Length: 24 Inch
CLOSE

Device Record Status

414f8874-e16a-4f89-bef9-c51ee46909a2
March 29, 2018
2
October 21, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)588-3100 214
ritaknight@acesurgical.com
CLOSE