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
9292
In Commercial Distribution
9292-25
Primed Instruments Inc
SuperDART® ONE PASS™ Validated Pull Through Three Stage Channel Cleaning Device. HIBC/UPN: M45392922
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
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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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
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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 |
Device Record Status
471b3752-97cb-4d05-a6bb-4e46afe2cd08
June 16, 2025
2
June 08, 2023
June 16, 2025
2
June 08, 2023
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M45392922 |
Unit of Use DI
[?]
Unit of Use DI Number:
00666416120772
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-565-0565
info@primedendo.com
info@primedendo.com