DEVICE: QUIKsheath Barriers T-Bar Light Handle (00723896009741)

Device Identifier (DI) Information

QUIKsheath Barriers T-Bar Light Handle
70-19724
In Commercial Distribution
70-19724
PRACTICON, INC.
00723896009741
GS1

500
119193803 *Terms of Use
duce contamination and cleanup time between patients for only pennies per sheath. Unique design pulls over light handles more easily for an effective barrier. Provides visual assurance of aseptic procedures. Sheaths measure 6.25" x 3".
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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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?
12535 Medical equipment/instrument drape, single-use
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PEM Dental Barriers And Sleeves
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d6426a5e-aa3f-4f97-bd60-5120b1d1af61
September 11, 2024
4
July 18, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00723896009758 20 00723896009741 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: 00723896002711 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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