AccessGUDID - DEVICE: ARMADA (00812261012605)

GUDID

Device Identifier (DI) Information

Brand Name: ARMADA
Version or Model: ARMADA Nottingham One Step Dilator 6F/10F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NOT 6/10
Company Name: ALLWIN MEDICAL DEVICES, INC.

Primary DI Number: 00812261012605
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796354509 *Terms of Use

Device Description: ARMADA Nottingham One Step Dilator 6F/10F

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZN	Dilator, Catheter, Ureteral

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: Yes
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: 9df158f9-26d0-4199-90e0-526721015a97
Public Version Date: August 08, 2023
Public Version Number: 1
DI Record Publish Date: July 31, 2023