AccessGUDID - DEVICE: Bone dust trap (00860006413903)

GUDID

Device Identifier (DI) Information

Brand Name: Bone dust trap
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rim Medical Technologies Incorporated

Primary DI Number: 00860006413903
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 254479645 *Terms of Use

Device Description: Device Description The sterile disposable, single-use surgical filter consists of a cylindrical container and dual filtrating system. Connection to the suction unit through the tubing is required to operate the device. The Bone Dust Trap is a filtration device for collecting bone dust and particles for subsequent bone graft implantation during various surgical procedures. The device can be emptied and further reused during a single operating procedure on the same patient.

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":	Yes
For Single-Use:	Yes
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?
47624	Bone graft harvesting filter	A sterile receptacle designed to collect morselized (cut/shredded into small pieces) bone and bone marrow typically obtained during an intramedullary procedure involving reaming, irrigation, and aspiration (suction). The filter is situated, with connection tubing, between the bone harvesting device (e.g., the orthopaedic reamer handpiece) and a suction system which creates vacuum to draw the graft into the filter where it is captured. The retrieved tissue is used for surgical procedures requiring bone graft (e.g., to facilitate bone fusion and/or fill bone defects). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDC	Instrument, Surgical, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 768bd6cd-d442-49af-a0de-d5a9b01941e7
Public Version Date: July 18, 2022
Public Version Number: 1
DI Record Publish Date: July 10, 2022