DEVICE: MediChoice (20885632291149)

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Device Record History
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Device Identifier (DI) Information
MediChoice
ES3501
In Commercial Distribution

OWENS & MINOR DISTRIBUTION, INC.
20885632291149
GS1

25
007941230 *Terms of Use
Exam Shorts SMS Elastic Waistband Meduim Dark Blue 1/EA 25PK 100 CA 35gsm Disposable Not Made with Natural Rubber Latex MediChoice
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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?
35492 Isolation gown, single-use
A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FME Gown, examination
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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:
Special Storage Condition, Specify: Keep Dry, Keep away from direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
300d191f-1b3b-4b5c-85ad-16e57e01eacd
March 11, 2021
1
March 03, 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
30885632291146 4 20885632291149 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: 10885632291142 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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