Hood
Flyte - 0408800000
Device Description
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.
Environmental Conditions
- 49.00
- N/A
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FYA
Device Name: Gown, Surgical
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.4040
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 34546540591716
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04546540591715
Package Quantity: 32
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 04546540591715
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A