AccessGUDID - DEVICE: NTI (E31018319SO1)

GUDID

Device Identifier (DI) Information

Brand Name: NTI
Version or Model: 183.19.SO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP205-ASST
Company Name: NTI - Kahla GmbH Rotary Dental Instruments

Primary DI Number: E31018319SO1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314810326 *Terms of Use

Device Description: NTI Peeso Reamers Asst Pk 19mm

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:	Yes
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?
31876	Endodontic enlarger, reusable	A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZA	DRILL, DENTAL, INTRAORAL

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94cb749c-b987-4b24-b388-fc9354df0489
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 01, 2022