AccessGUDID - DEVICE: Carnegie Surgical LLC (G141514231000)

GUDID

Device Identifier (DI) Information

Brand Name: Carnegie Surgical LLC
Version or Model: 514-23100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 514-23100
Company Name: Carnegie Surgical LLC

Primary DI Number: G141514231000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017636482 *Terms of Use

Device Description: Hone Arkansas Stone, Wedge Shaped, Size 10 x 4 cm

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?
47876	Orthopaedic bone pin sharpener	A hand-held manual surgical instrument used to alter the tip of a bioabsorbable bone pin, e.g., to shorten it, prior to insertion into the patient. It is typically designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a sharpener with a cutting blade similar in design to a pencil sharpener. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon or assistive surgical staff inside the sterile field of the operating room (OR). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEO	File, Surgical, General & Plastic Surgery

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: 30f6946a-4429-435d-93b6-254183808526
Public Version Date: February 11, 2025
Public Version Number: 1
DI Record Publish Date: February 03, 2025