AccessGUDID - DEVICE: Cleaning Brush φ1.0 (06902139111166)

GUDID

Device Identifier (DI) Information

Brand Name: Cleaning Brush φ1.0
Version or Model: 110191000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110191000
Company Name: Double Medical Technology Inc.

Primary DI Number: 06902139111166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529366055 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35589	Intramedullary canal cleaning brush, reusable	A hand-held manual surgical instrument designed to remove blood clots and bone debris from the intramedullary canal of a bone (marrow space) in preparation for the insertion of orthopaedic cement. It typically consists of a handle at the proximal end and bristles, fibres, or spines at the distal end which may be soft or stiff and are mounted along a single plane or radiate out around a central shaft which may be flexible or rigid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130108	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 297c5033-cc6b-4137-93a1-aa1d39f95887
Public Version Date: September 10, 2024
Public Version Number: 5
DI Record Publish Date: September 01, 2016