DEVICE: ACE (00614950017034)
Device Identifier (DI) Information
ACE
0034218
In Commercial Distribution
0034218
ACE SURGICAL SUPPLY CO., INC.
0034218
In Commercial Distribution
0034218
ACE SURGICAL SUPPLY CO., INC.
AUTOGRAFTER WITH HVAC VARIJET
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? |
---|---|---|---|---|
44888 | Dental bone particle collector |
A small container designed as a bone-harvesting device (bone trap) to collect autologous bone fragments, e.g., when drilling in the jawbone during a dental implant surgical procedure. It functions as a filter that traps the bone particles and is typically placed in a suction tube line between the site of operation and the suction unit. The harvested bone particles may be saved for future use. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
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
fdbd9467-7a9b-4e70-b0e3-01eff94e4155
October 18, 2019
1
October 10, 2019
October 18, 2019
1
October 10, 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