AccessGUDID - DEVICE: UNIVERSITY OF TEXAS SCALER (00192896082427)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSITY OF TEXAS SCALER
Version or Model: 1102-SCUT107-108
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1102-SCUT107-108
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896082427
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: UNIVERSITY OF TEXAS SCALER #107-108 DOUBLE ENDED BLADES

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):	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?
35320	Manual dental scaler, reusable	A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMN	SCALER, PERIODONTIC

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 [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 40 Degree Shank
Device Size Text, specify: 13 Millimeter Reach
Device Size Text, specify: 1 Millimeter Blades

Device Record Status

Public Device Record Key: 10bac778-0c19-46ac-82ad-41ed2bb9617e
Public Version Date: September 17, 2019
Public Version Number: 6
DI Record Publish Date: September 21, 2018