AccessGUDID - DEVICE: Nobel Biocare® (07332747176445)

GUDID

Device Identifier (DI) Information

Brand Name: Nobel Biocare®
Version or Model: 300439
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 300439
Company Name: Nobel Biocare AB

Primary DI Number: 07332747176445
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Guided Pilot Drill Sleeve 1.5mm 20/pkg

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?
57789	Surgical drill guide, single-use	A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, implant, dental, endosseous

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 [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight. Keep dry

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 1.500 Millimeter

Device Record Status

Public Device Record Key: 035f82f4-1bc8-4876-8a1b-26d3b7029ca9
Public Version Date: October 25, 2023
Public Version Number: 3
DI Record Publish Date: July 22, 2022