AccessGUDID - DEVICE: Nordent Manufacturing, Inc. (00840018668317)

GUDID

Device Identifier (DI) Information

Brand Name: Nordent Manufacturing, Inc.
Version or Model: Hartzell Gracey 11 Rigid
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: NORDENT MANUFACTURING INC

Primary DI Number: 00840018668317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053187985 *Terms of Use

Device Description: Scaler, Cone Socket Tip, Hartzell Gracey 11 Rigid, SST

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):	Yes
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
ELA	Instrument, Hand, Calculus Removal

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
Handling Environment Humidity: between 40 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 350 Degrees Fahrenheit
Storage Environment Humidity: between 40 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 65 and 75 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 6.5 Inch

Device Record Status

Public Device Record Key: ae63253f-98ec-4acb-bbcf-109032f6e8a9
Public Version Date: November 03, 2025
Public Version Number: 1
DI Record Publish Date: October 24, 2025