Model: PK45601
Catalog: PK45601
DI: 10620974004483
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
Twisted Wire Brush 18” 1mm
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1ab82c94-6cf1-4255-bb0e-e5c32fcf0e47
Distribution Status:
In Commercial Distribution
DUNS Number:
246848147
Device Count:
3
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00620974004486
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10620974004483
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 34878
Name: Surgical instrument/endoscope cleaning utensil, reusable
Definition:
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 reusable device.
FDA Product Codes
GEC
BRUSH, SCRUB, OPERATING-ROOM