AccessGUDID - DEVICE: AMD-RITMED SOLON (10686864046070)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED SOLON
Version or Model: 57502
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 57502
Company Name: AMD Medicom Inc

Primary DI Number: 10686864046070
Issuing Agency: GS1
Commercial Distribution End Date: July 03, 2024
Device Count: 100
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED SOLON RAYON TIPPED PROCTOSCOPIC APPLICATORS 16 Inch

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXF	APPLICATOR, ABSORBENT TIPPED, NON-STERILE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Room temperature
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16 Inch

Device Record Status

Public Device Record Key: 1ae7ccf5-6fd5-4d32-82ad-2b3f4a20ab33
Public Version Date: July 04, 2024
Public Version Number: 3
DI Record Publish Date: January 14, 2019