DEVICE: PULL THRU™ Cleaning Brush (09421028490436)

Device Identifier (DI) Information

PULL THRU™ Cleaning Brush
CSD0912+6+0+610/09 - CSSD Instrument cleaning brush
In Commercial Distribution
CSD0912+6+0+610/09
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
09421028490436
GS1

6
591592316 *Terms of Use
6 x Channel cleaning brush, channel ID 9.0mm-12.0mm, length 610mm, 4x360 degree wipers
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
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FDA Product Code

[?]
Product Code Product Code Name
MNL Accessories, Cleaning Brushes, For Endoscope
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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
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

524533c2-3dc4-4c28-b3ba-53d58cb75fc6
November 18, 2022
1
November 10, 2022
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 09421028493505 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+6498189558
info@pullthru.net.nz
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