AccessGUDID - DEVICE: AMD-RITMED (20686864042840)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: 53217
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 53217
Company Name: AMD Medicom Inc

Primary DI Number: 20686864042840
Issuing Agency: GS1
Commercial Distribution End Date: September 06, 2023
Device Count: 500
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED CYLINDRICAL SPONGES X-RAY DETECTABLE 3/8 X 3/4 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):	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?
58232	Cotton wool roll	A device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3/8 X 3/4 Inch

Device Record Status

Public Device Record Key: 36b438e8-3a31-4f7c-88b3-a0677f5190a9
Public Version Date: September 07, 2023
Public Version Number: 4
DI Record Publish Date: January 16, 2019