AccessGUDID - DEVICE: ARKANSAS HARD SHARPENER (00192896090606)

GUDID

Device Identifier (DI) Information

Brand Name: ARKANSAS HARD SHARPENER
Version or Model: 1100-5821
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1100-5821
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896090606
Issuing Agency: GS1
Commercial Distribution End Date: August 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: ARKANSAS HARD SHARPENER IN CASE

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:	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?
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
EMI	File, Bone, 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
Dry Heat 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: 8c443464-6e60-4fb3-b6ed-2315a19b743b
Public Version Date: August 10, 2023
Public Version Number: 3
DI Record Publish Date: March 07, 2019