AccessGUDID - DEVICE: N.A. (J011744101010)

GUDID

Device Identifier (DI) Information

Brand Name: N.A.
Version or Model: 744-101-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011744101010
Issuing Agency: HIBCC
Commercial Distribution End Date: November 16, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: Neck pads for neck bands, blue

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?
31757	Orthodontic extraoral headgear	A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZB	Headgear, extraoral, orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K936151	000

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
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: 77f59bee-aaf2-4a03-ace2-36effe9f5037
Public Version Date: November 16, 2021
Public Version Number: 4
DI Record Publish Date: September 15, 2016