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

Device Identifier (DI) Information

5PK QUICK FIT HEAD CAP *O
300-104
In Commercial Distribution
300-104
GREAT LAKES ORTHODONTICS, LTD.
D7753001040
HIBCC

1
041854332 *Terms of Use
5PK QUICK FIT HEAD CAP *O
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
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).
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DZB Headgear, Extraoral, Orthodontic
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5ec61d5b-d3b7-4e32-aa3f-6bf65fb98bc8
March 29, 2018
2
May 18, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
8008287626
info@greatlakesortho.com
CLOSE