DEVICE: ACE (00614950020577)

Device Identifier (DI) Information

ACE
20155001
In Commercial Distribution
20155001
ACE SURGICAL SUPPLY CO., INC.
00614950020577
GS1

1
042763706 *Terms of Use
THUMB KNOB FOR HEX DRIVER/ DELIVERY TOOL KNURLED TI
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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?
61946 Surgical torque wrench adaptor
A component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EJB HANDLE, INSTRUMENT, DENTAL
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: No special storage conditions required
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

24b4bbbc-f583-4f25-b775-2b59f36baa36
October 28, 2019
1
October 19, 2019
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)441-3100
ritaknight@acesurgical.com
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