AccessGUDID - DEVICE: Concave Tip Offset Osteotome Kit (D785OSTOSCKIT0)

GUDID

Device Identifier (DI) Information

Brand Name: Concave Tip Offset Osteotome Kit
Version or Model: Concave Tip Offset Osteotome Kit (3)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OST-OS-C Kit
Company Name: OCO BIOMEDICAL INC

Primary DI Number: D785OSTOSCKIT0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094146123 *Terms of Use

Device Description: Concave Tip Offset Osteotome Kit (3) All 3 with case 2.65mm Concave Tip Offset Osteotome 3.4mm Concave Tip Offset Osteotome 4.4mm Concave Tip Offset Osteotome

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44886	Dental osteotome set	A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

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: 44913c50-34ac-4fcb-8edb-db698a6673c7
Public Version Date: February 23, 2024
Public Version Number: 3
DI Record Publish Date: April 29, 2016