DEVICE: MARK3 (D79614040)

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Device Record History
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Device Identifier (DI) Information
MARK3
1404
In Commercial Distribution

CARGUS INTERNATIONAL, INC
D79614040
HIBCC

1
096191093 *Terms of Use
Headrest Covers Paper 10"x10" White 500/bx. - MARK3
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
35880 Examination/treatment table paper
A non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NRD Unit, Operative Dental, Accessories
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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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in cool, dry place.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
019620f2-5e51-4fab-839f-aed546285782
May 05, 2021
1
April 27, 2021
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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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