AccessGUDID - DEVICE: Amsco Eagle (00724995152017)

GUDID

Device Identifier (DI) Information

Brand Name: Amsco Eagle
Version or Model: 3017
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FF85
Company Name: Steris Mexico, S. de R.L. de C.V.

Primary DI Number: 00724995152017
Issuing Agency: GS1
Commercial Distribution End Date: October 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 813116209 *Terms of Use

Device Description: The Amsco Eagle EO Sterilizer, Tabletop 100% ethylene oxide (EO) gas sterilizer/aerator provides effective low-temperature sterilization of heat-sensitive items.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13740	Ethylene oxide sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using ethylene oxide (ETO) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and packed in gas permeable wraps; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLF	Sterilizer, ethylene-oxide gas

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K931872	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25dddb8f-a00c-41ad-bfbb-13279fbebe95
Public Version Date: October 09, 2020
Public Version Number: 6
DI Record Publish Date: September 14, 2016