DEVICE: Halyard (10680651795776)
Device Identifier (DI) Information
Halyard
79577
In Commercial Distribution
79577
O&M HALYARD, INC.
79577
In Commercial Distribution
79577
O&M HALYARD, INC.
HALYARD* EVOLUTION* 4 Standard Non-Reinforced Surgical Gown, Drop Fold
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
35091 | Surgical gown, single-use |
A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it 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 single-use garment.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KKX | Drape, surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K842115 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
019ac8e2-00ca-4c02-a509-25e2103162cf
November 01, 2021
3
July 17, 2020
November 01, 2021
3
July 17, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30680651795770 | 12 | 10680651795776 | In Commercial Distribution | CS |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
90680651795772
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(844)425-9273
PIQ@hyh.com
PIQ@hyh.com