DEVICE: Henry Schein (00304040004036)

Device Identifier (DI) Information

Henry Schein
1068473
In Commercial Distribution
1068473
HENRY SCHEIN, INC.
00304040004036
GS1

1
012430880 *Terms of Use
Ortho Primer Refill
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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 bracket adhesive A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DYH ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep out of sun
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 24 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Bottle
Total Volume: 9 Milliliter
CLOSE

Device Record Status

a31bd67a-65a4-487d-bfbd-22e77760d26e
March 29, 2018
2
September 24, 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE