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.
00723896006009
GS1

4
119193803 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FSM Tray, Surgical, Instrument
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FDA Premarket Submission

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

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

e5251bcb-9e69-4e39-bcde-dc85b8067a57
May 03, 2023
2
October 10, 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
00723896006160 50 00723896006009 In Commercial Distribution Case
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Secondary DI

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

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Unit of Use DI Number: 00723896001578 CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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