DEVICE: Flyte (04546540591791)
Device Identifier (DI) Information
Flyte
0408820100
In Commercial Distribution
0408820100
STRYKER CORPORATION
0408820100
In Commercial Distribution
0408820100
STRYKER CORPORATION
Toga, Peel-Away Large
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 |
---|---|
Operating room gown, single-use | 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 single-use garment. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FYA | GOWN, SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 49 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9e63ce70-3698-4a85-a5b9-024aa8195798
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 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 |
---|---|---|---|---|---|
34546540591792 | 9 | 04546540591791 | In Commercial Distribution | pack |
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)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com