DEVICE: Henry Schein/DE (00304040005965)

Device Identifier (DI) Information

Henry Schein/DE
9004685
In Commercial Distribution
9004685
HENRY SCHEIN, INC.
00304040005965
GS1

50
012430880 *Terms of Use
HS Sterile Drape Fenestrated,18x26" 2.75"d hole
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General-purpose surgical drape, single-use, sterile A sterile protective covering made of natural or synthetic materials, or both, designed to isolate a site of surgical incision or a surgical field from contamination (e.g., microbial, substance) in various clinical settings (e.g., in an operating room or catheterization laboratory). The device may also be used to protect a patient from heat/flame during a surgical procedure. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KKX Drape, surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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

[?]
Size Type Text
Weight: 14 Gram
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Device Record Status

6cd0054e-445a-40f4-bbda-9eec787ccb6c
March 29, 2018
2
September 24, 2016
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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
10304040005962 6 00304040005965 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

[?]
Unit of Use DI Number: 20304040005969 CLOSE

Direct Marking (DM)

[?]
Yes
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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