AccessGUDID - DEVICE: Brånemark System® (07332747013078)

GUDID

Device Identifier (DI) Information

Brand Name: Brånemark System®
Version or Model: 32632
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32632
Company Name: Nobel Biocare AB

Primary DI Number: 07332747013078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Bmk Syst Zygoma Twist Drill 3.5 mm short

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
Fluted surgical drill, single-use, non-sterile	A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in various sizes. This is a single-use device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Fluted surgical drill, single-use, non-sterile

A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in various sizes. This is a single-use device intended to be sterilized prior to use.

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: 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
Outer Diameter: 3.500 Millimeter

Device Record Status

Public Device Record Key: 918b5f4c-41c3-4c89-93f7-254960bd2655
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016