AccessGUDID - DEVICE: NobelReplace® (07332747006209)

GUDID

Device Identifier (DI) Information

Brand Name: NobelReplace®
Version or Model: 32244
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 32244
Company Name: Nobel Biocare AB

Primary DI Number: 07332747006209
Issuing Agency: GS1
Commercial Distribution End Date: March 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Drill w Tip Tapered 2mm

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45714	Fixture/appliance dental drill bit, reusable	A 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 manual or power tool handpiece that provides rotation. This is a reusable device.	Active	false

FDA Product Code

[?]

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: 2.000 Millimeter

Device Record Status

Public Device Record Key: 1f9a3baa-e72c-445b-9dfc-1b7a1da691ce
Public Version Date: April 27, 2021
Public Version Number: 6
DI Record Publish Date: September 17, 2016