AccessGUDID - DEVICE: Osstell SmartPeg Type 15 (09010522001295)

GUDID

Device Identifier (DI) Information

Brand Name: Osstell SmartPeg Type 15
Version or Model: Osstell SmartPeg Type 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100386
Company Name: Osstell AB

Primary DI Number: 09010522001295
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 633171269 *Terms of Use

Device Description: ISQ Measurement Peg

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?
63468	Dental implant stability resonance frequency analysis peg	A small, screw-like device intended to be attached to a dental implant or abutment to measure the stability of the implant. It is used with a control unit (not included) which provides an electromagnetic pulsation to create a noninvasive vibrating force in the peg, and the subsequent degree of peg movement provides a measure of dental implant stability [typically referred to as resonance frequency analysis (RFA)]. This measurement can be repeated over time to help assess the progress of implant osseointegration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKX	Handpiece, Direct Drive, Ac-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
No Device Sizes

Device Record Status

Public Device Record Key: c021746b-cc3a-4dba-ae24-87c102a3de0e
Public Version Date: September 19, 2024
Public Version Number: 2
DI Record Publish Date: September 02, 2022