AccessGUDID - DEVICE: SuperDART® ONE PASS™ Validated Channel Cleaning Kit (00666416121274)

GUDID

Device Identifier (DI) Information

Brand Name: SuperDART® ONE PASS™ Validated Channel Cleaning Kit
Version or Model: 9355
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9355-25
Company Name: Primed Instruments Inc

Primary DI Number: 00666416121274
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9253 + 9990). HIBC/UPN: M45393552

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
38835	Surgical instrument/endoscope cleaning utensil, single-use	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

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: Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61d61199-b558-4d2b-9636-b082c0ea6a96
Public Version Date: June 23, 2025
Public Version Number: 1
DI Record Publish Date: June 13, 2025