AccessGUDID - DEVICE: NA (07630031720290)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: surgically Invasive Instruments
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 044.342
Company Name: Institut Straumann AG

Primary DI Number: 07630031720290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: Explantation drill, long, for Ø 4.1mm L 40.5mm, stainless steel

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?
62719	Crown surgical drill bit, single-use	A non-sterile shaft of metal with a hollow centre designed for overdrilling a surgical screw or screw shaft to expose it for its removal, with another instrument, when the screw head has become defective or detached. The device is commonly called a "hollow mill" or "crown drill", but may also be referred to as a "hollow reamer", and is designed as a cylindrical hollow shell with a thin wall that has saw teeth at the cutting edge. It is inserted into a surgical power tool for rotation. This device may also be used to obtain core bone biopsies. 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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.1 Millimeter
Length: 40.5 Millimeter

Device Record Status

Public Device Record Key: 7f4af0a0-df18-40e2-9f65-c67e270fc603
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022