AccessGUDID - DEVICE: BONE FILE #52X CROSS CUT OLSEN HANDLE D/E DLC **SPECIAL ORDER** (D928105252XDLCHO0)

GUDID

Device Identifier (DI) Information

Brand Name: BONE FILE #52X CROSS CUT OLSEN HANDLE D/E DLC **SPECIAL ORDER**
Version or Model: 10-5252XDLCH/O
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W.H. Holden, Inc.

Primary DI Number: D928105252XDLCHO0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183854322 *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):	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?
64007	Bone file/rasp, reciprocating, single-use	A surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a single-use 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

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: fe698922-5cfc-4428-bbc6-02d73ea4ccb3
Public Version Date: October 18, 2023
Public Version Number: 1
DI Record Publish Date: October 10, 2023