DEVICE: Alcon Eye-Pak (00380651126206)
Device Identifier (DI) Information
Alcon Eye-Pak
8065112620
In Commercial Distribution
Alcon Laboratories, Inc.
8065112620
In Commercial Distribution
Alcon Laboratories, Inc.
Eye Pak* 1126 Plastic Ophthalmic Drape INCISE
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 |
---|---|
Patient surgical drape, single-use, sterile | A sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HMT | Drape, patient, ophthalmic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K830822 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5ec43bfa-67a6-4079-b85e-9a24734438a6
November 08, 2018
4
September 24, 2016
November 08, 2018
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10380651126203 | 20 | 00380651126206 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)862-5266
web.masterus@alcon.com
web.masterus@alcon.com