AccessGUDID - DEVICE: AMD-RITMED (10686864043758)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: 76522
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 76522
Company Name: AMD Medicom Inc

Primary DI Number: 10686864043758
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED NASAL PACKING STRUNG X-RAY DETECTABLE 1/2 X 2 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?
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). 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: Yes
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: 1/2 X 2 Inch

Device Record Status

Public Device Record Key: 6c92c74b-f5a5-4c6b-9277-8309f0dcfc3a
Public Version Date: December 13, 2023
Public Version Number: 2
DI Record Publish Date: January 16, 2019