AccessGUDID - DEVICE: NA (07630031745149)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: surgically Invasive Instruments
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 040.584S
Company Name: Institut Straumann AG

Primary DI Number: 07630031745149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: Drill Stop Set, Type A, for drill Ø 2.2 - 4.2mm, short 12mm

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?
67356	Surgical instrument/implant depth limiter, single-use	A device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit, reamer, electrode), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of stainless steel and/or synthetic polymer materials and is available in a variety of shapes and lengths. 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.2 Millimeter

Device Record Status

Public Device Record Key: bd0d3742-03f7-43a2-9bd7-d83e6ac9238d
Public Version Date: December 24, 2024
Public Version Number: 3
DI Record Publish Date: December 02, 2022