AccessGUDID - DEVICE: Carnegie Surgical LLC (G141588190150)

GUDID

Device Identifier (DI) Information

Brand Name: Carnegie Surgical LLC
Version or Model: 588-19015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 588-19015
Company Name: Carnegie Surgical LLC

Primary DI Number: G141588190150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017636482 *Terms of Use

Device Description: Waste Bucket, 15 litre

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):	No
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?
14427	Kick bucket	A device typically made of stainless steel that is used as a receptacle for refuse in an operating room (OR) or treatment room where surgery is performed. The refuse is typically packaging, plastic coverings, or cotton balls. Surgical sponges are not generally thrown into this device as they should be accounted for and collected on a special rack until the end of the intervention. The device is typically mounted in a low stand with wheels so that it may be easily moved with a kick of the foot, hence the name "kick bucket". A liner is usually used to improve hygiene.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRP	Tray, Surgical

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: 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: 5d21acb4-cba5-4050-8bc4-8478d18eabc2
Public Version Date: February 26, 2024
Public Version Number: 1
DI Record Publish Date: February 16, 2024