DEVICE: 9000 Series Disposable Channel Cleaning Brush (00666416120048)

Device Identifier (DI) Information

9000 Series Disposable Channel Cleaning Brush
9025
In Commercial Distribution
9025-50
Primed Instruments Inc
00666416120048
GS1

50
254491293 *Terms of Use
Disposable Channel Cleaning Micro Brush. HIBC/UPN: M45390253
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
Yes
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 brushes in original packaging at room temperature in a dry clean location away from direct sunlight. Each dispenser box contains 50 individually packed cleaning brushes.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Minimum Channel Size: 1.2mm
Device Size Text, specify: Brush Diameter: 2.5mm
Device Size Text, specify: Overall Length: 120cm
CLOSE

Device Record Status

6c3b796f-805e-49b9-b289-97ac0b8b3ceb
June 14, 2023
5
October 23, 2017
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 M45390253
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00666416120413 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