AccessGUDID - DEVICE: Bone Caliper (00083208130106)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Caliper
Version or Model: Bone Caliper
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Bone Caliper
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208130106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Bone caliper is used during surgery to determine/confirm the width and or other dimensions of bone, in millimeters, that is available for Implant placement

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:	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?
35788	Orthopaedic bone calliper	A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. 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: 6261792b-ec2b-427d-9633-9b3d59bea343
Public Version Date: February 11, 2021
Public Version Number: 1
DI Record Publish Date: February 03, 2021