AccessGUDID - DEVICE: OSTEOTOME RE - 3.5mm HF MARKINGS 4-6-8-10-13-15-18 (D92810516335HF0)

GUDID

Device Identifier (DI) Information

Brand Name: OSTEOTOME RE - 3.5mm HF MARKINGS 4-6-8-10-13-15-18
Version or Model: 10-5163-35HF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W.H. Holden, Inc.

Primary DI Number: D92810516335HF0
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?
44887	Dental osteotome	A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFI	OSTEOTOME, MANUAL

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: 8dcaa428-c207-4578-a868-eeadfb5c839d
Public Version Date: October 18, 2023
Public Version Number: 1
DI Record Publish Date: October 10, 2023