AccessGUDID - DEVICE: tomas® (J011302013010)

GUDID

Device Identifier (DI) Information

Brand Name: tomas®
Version or Model: 302-013-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011302013010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: tomas® anchorage system: tomas®-stop screw (Stop screws without hexagon socket key)

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?
31759	Orthodontic tube	A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAT	Implant, endosseous, orthodontic

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 7b38af1e-3fcb-4003-bd4c-744907ba05c3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2016