AccessGUDID - DEVICE: NA (07332747092646)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 38059
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 38059
Company Name: Nobel Biocare AB

Primary DI Number: 07332747092646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Guided Tissue Punch NP-sleeve (3.75)

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

GMDN Preferred Term Name	GMDN Definition
Gingival punch, reusable	A dental instrument used to remove with precision a circular area of gum tissue during dental surgery, to allow access to a site for drilling and dental implant placement without the use of a scalpel. It will typically be designed with a handle at the proximal end or for mounting into a dental drill, and have a cylindrical hollow tube-like head with a sharp cutting edge at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Gingival punch, reusable

A dental instrument used to remove with precision a circular area of gum tissue during dental surgery, to allow access to a site for drilling and dental implant placement without the use of a scalpel. It will typically be designed with a handle at the proximal end or for mounting into a dental drill, and have a cylindrical hollow tube-like head with a sharp cutting edge at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

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: 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: 3.750 Millimeter

Device Record Status

Public Device Record Key: 72fd47cb-0566-4fc1-9369-2989f1f2174f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016