AccessGUDID - DEVICE: NA (07332747065497)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 37094
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 37094
Company Name: Nobel Biocare AB

Primary DI Number: 07332747065497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Dense Bone Drill Tapered NP 3.5x13 mm Single-Patient Use

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:	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Fixture/appliance dental drill bit, single-use	A sterile shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Fixture/appliance dental drill bit, single-use

A sterile shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DZI	DRILL, BONE, POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.500 Millimeter
Length: 13.000 Millimeter

Device Record Status

Public Device Record Key: 2b6e55e4-2297-49db-a3d1-1b6aab61cd0e
Public Version Date: November 22, 2018
Public Version Number: 3
DI Record Publish Date: September 17, 2016