AccessGUDID - DEVICE: H.I.T. (D746828HT1)

GUDID

Device Identifier (DI) Information

Brand Name: H.I.T.
Version or Model: 828HT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 828HT
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D746828HT1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 18, 2021
Device Count: 50
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: H.I.T. - Tack System-Hooks/Pk of 50

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":	Yes
For Single-Use:	Yes
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?
33209	Orthodontic pliers	A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXC	Aligner, sequential

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: 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: 860804ae-863b-404c-b102-090d90254f40
Public Version Date: March 01, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016