AccessGUDID - DEVICE: NTI (E310ML007B1)

GUDID

Device Identifier (DI) Information

Brand Name: NTI
Version or Model: ML007B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 305-050LH
Company Name: NTI - Kahla GmbH Rotary Dental Instruments

Primary DI Number: E310ML007B1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314810326 *Terms of Use

Device Description: NTI Left Hand Mandrels

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?
31868	Dental laboratory mandrel	A round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJQ	WHEEL, POLISHING AGENT

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: 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: 7cc4af3f-0f00-47dc-b6b6-4eec11c3a7cc
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 01, 2022