DEVICE: Medichoice (10885632131714)

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Device Record History
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Device Identifier (DI) Information
Medichoice
ORT04WX
In Commercial Distribution

OWENS & MINOR DISTRIBUTION, INC.
10885632131714
GS1

4
007941230 *Terms of Use
MediChoice O.R. Towel, X-Ray Detectable, 16 Inch X 24 Inch, White (Case Of 80)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
14077 Surgical towel
A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KKX Drape, surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K001858 000
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
3b44c576-88b2-4249-a701-ebbaa9ee45df
July 06, 2018
3
August 20, 2016
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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
50885632131712 20 10885632131714 In Commercial Distribution
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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: 60885632131719 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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