AccessGUDID - DEVICE: Obtura Spartan (00816168020640)

GUDID

Device Identifier (DI) Information

Brand Name: Obtura Spartan
Version or Model: 941-109
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 941-109
Company Name: OBTURA SPARTAN ENDODONTICS

Primary DI Number: 00816168020640
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078371330 *Terms of Use

Device Description: Tip Set of 8 PST 1-8 Contains: 941-101 Tip PST-1 DI# 00816168020565 941-102 Tip PST-2 DI# 00816168020572 941-103 Tip PST-3 DI# 00816168020589 941-104 Tip PST-4 DI# 00816168020596 941-105 Tip PST-5 DI# 00816168020602 941-106 Tip PST-6 DI# 00816168020619 941-107 Tip PST-7 DI# 00816168020626 941-108 Tip PST-8 DI# 00816168020633

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):	No
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?
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

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
No Device Sizes

Device Record Status

Public Device Record Key: e437cfa0-3e39-4a27-9154-ca895705ec4e
Public Version Date: September 27, 2022
Public Version Number: 3
DI Record Publish Date: October 03, 2016