DEVICE: Alcon Eye-Pak (00380651120204)

Device Identifier (DI) Information

Alcon Eye-Pak
8065112020
In Commercial Distribution

Alcon Laboratories, Inc.
00380651120204
GS1

1
008018525 *Terms of Use
Eye Pak* 1120 Plastic Ophthalmic Drape INCISE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
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

[?]
Product Code Product Code Name
HMT Drape, patient, ophthalmic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K830822 000
No CLOSE

Sterilization

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

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

942b7af1-0125-4b29-901e-8c5e33f6b78d
July 06, 2018
3
September 24, 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
10380651120201 10 00380651120204 In Commercial Distribution Box
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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: 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
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)862-5266
web.masterus@alcon.com
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