AccessGUDID - DEVICE: ArcRoyal Anti-Fog, Regular Solution, Sterile (00840113230433)

GUDID

Device Identifier (DI) Information

Brand Name: ArcRoyal Anti-Fog, Regular Solution, Sterile
Version or Model: AR-7304412
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00840113230433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Intended to be used as an anti-fog agent for endoscopic camera lenses

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?
45225	Endoscope antifog solution	A liquid substance intended to be used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCT	Anti fog solution and accessories, endoscopy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932449	000

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: b1d2e51e-d4e3-4dc4-b30b-ba3ad8697054
Public Version Date: January 20, 2023
Public Version Number: 2
DI Record Publish Date: February 25, 2021