DEVICE: BurSafe Bur Holders- True Blue (00723896006009)
Device Identifier (DI) Information
BurSafe Bur Holders- True Blue
53C9060
In Commercial Distribution
70-39730-BLU
PRACTICON, INC.
53C9060
In Commercial Distribution
70-39730-BLU
PRACTICON, INC.
Bur storage, sterilization, and retrieval easier and safer than ever. Unique design stores six burs horizontally, and removal is as simple as pressing down on one end. Two models accommodate both FG and RA Burs and side easily into small, flat sterilization pouches. Fully sterilization to 375 degree F.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
62851 | Surgical instrument interim-placement holder, reusable |
A device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FSM | Tray, Surgical, Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e5251bcb-9e69-4e39-bcde-dc85b8067a57
May 03, 2023
2
October 10, 2019
May 03, 2023
2
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 |
---|---|---|---|---|---|
00723896006160 | 50 | 00723896006009 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00723896001578
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined