AccessGUDID - DEVICE: AMD-RITMED (10686864040061)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: A92100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A92100
Company Name: AMD Medicom Inc

Primary DI Number: 10686864040061
Issuing Agency: GS1
Commercial Distribution End Date: August 27, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: 2 IN x 100 FT STERILIZATION REEL

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":	Yes
For Single-Use:	Yes
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?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCT	Sterilization wrap containers, trays, cassettes & other accessories

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 Inch x 100 Feet

Device Record Status

Public Device Record Key: b2a72f6c-94df-4a7e-ad8f-55d9d374d0b0
Public Version Date: November 08, 2019
Public Version Number: 5
DI Record Publish Date: September 15, 2016