AccessGUDID - DEVICE: Prosthesis, Hawley Retainer, Palatal Expander, Spacer, Herbst, Nance HoldingArch (06970617030100)

GUDID

Device Identifier (DI) Information

Brand Name: Prosthesis, Hawley Retainer, Palatal Expander, Spacer, Herbst, Nance HoldingArch
Version or Model: Not Applicable
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHENZHEN MINGHAO DENTURES CO., LTD.

Primary DI Number: 06970617030100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 526027843 *Terms of Use

Device Description: No description.

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthodontic retainer	A dental orthodontic appliance, fixed or removable, used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

FDA Product Code

[?]

Product Code	Product Code Name
NSR	Prosthesis, 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: Yes

Sterilization Method [?]
Ultraviolet Light

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: 116a7fdd-f13b-42be-8604-f4d93126a520
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 14, 2016