AccessGUDID - DEVICE: Flyte (04546540591791)

GUDID

Device Identifier (DI) Information

Brand Name: Flyte
Version or Model: 0408820100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0408820100
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540591791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Toga, Peel-Away Large

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
FYA	GOWN, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 49 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e63ce70-3698-4a85-a5b9-024aa8195798
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016