AccessGUDID - DEVICE: N.A. (J011602604100)

GUDID

Device Identifier (DI) Information

Brand Name: N.A.
Version or Model: 602-604-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011602604100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: Three dimensional screw acc. to Steiner, individually adjustable middle bar, two movements, Stainless Steel

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:	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?
65678	Orthodontic palate expander screw, self-removable	An orthodontic device intended to be used as part of a self-removable palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is not fixed to the oral cavity so that it can be temporarily removed by the patient during the treatment period (e.g., for eating). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYJ	RETAINER, SCREW EXPANSION, ORTHODONTIC

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
Special Storage Condition, Specify: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff75c61a-7ba6-40ee-b44a-6800caaf34c8
Public Version Date: November 16, 2021
Public Version Number: 5
DI Record Publish Date: September 15, 2016