DEVICE: Lac-Mac (06277550056137)

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Device Identifier (DI) Information

Lac-Mac
005XFAE-2XL
005XFAE-2XL
Lac-Mac Limited
06277550056137
GS1
1
Surgical Gown, Level 3, tie closure, knit neckband, raglan sleeves, patented Size 2XL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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
Operating room gown, reusable A garment made of natural and/or synthetic materials intended to be worn over a scrub suit during a surgical procedure; it may be fluid resistant or impervious to fluids. An operating room (OR) gown is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment intended to be laundered after each use.
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FDA Product Code

[?]
Product Code Product Code Name
FYA Gown, Surgical
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
Height: 57.25 Inch
Width: 29 Inch
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Device Status

In Commercial Distribution
September 21, 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
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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
5194322616
glankin@lac-mac.com
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