DEVICE: 9000 Series Disposable Channel Cleaning Brush (00666416120758)

Device Identifier (DI) Information

9000 Series Disposable Channel Cleaning Brush
9292
In Commercial Distribution
9292-25
Primed Instruments Inc
00666416120758
GS1

25
254491293 *Terms of Use
SuperDART® ONE PASS™ Validated Pull Through Three Stage Channel Cleaning Device. HIBC/UPN: M45392922
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNL Accessories, Cleaning Brushes, For Endoscope
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Range of Channel Size: 2.8-4.2mm
Length: 250 Centimeter
Device Size Text, specify: Minimum Channel Size 2.0mm
Device Size Text, specify: Brush Diameter: 3-6.3mm
Device Size Text, specify: Overall Length: 240cm
CLOSE

Device Record Status

471b3752-97cb-4d05-a6bb-4e46afe2cd08
June 16, 2025
2
June 08, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC M45392922
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00666416120772 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-877-565-0565
info@primedendo.com
CLOSE