AccessGUDID - DEVICE: 5PK QUICK FIT HEAD CAP *O (D7753001040)

GUDID

Device Identifier (DI) Information

Brand Name: 5PK QUICK FIT HEAD CAP *O
Version or Model: 300-104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300-104
Company Name: Great Lakes Dental Technologies, Ltd.

Primary DI Number: D7753001040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041854332 *Terms of Use

Device Description: 5PK QUICK FIT HEAD CAP *O

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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ec61d5b-d3b7-4e32-aa3f-6bf65fb98bc8
Public Version Date: February 02, 2021
Public Version Number: 3
DI Record Publish Date: May 18, 2016