AccessGUDID - DEVICE: Henry Schein (00304040005811)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1065167
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1065167
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040005811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Ortho Bracket Adhes Kit

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.
Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

FDA Product Code

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Product Code	Product Code Name
KLE	AGENT, TOOTH BONDING, RESIN
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

FDA Premarket Submission

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

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

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Storage and Handling
Special Storage Condition, Specify: Keep out of sun
Storage Environment Temperature: between 35 and 50 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Total Volume: 9 Milliliter
Device Size Text, specify: Etching Agent
Weight: 9 Gram
Device Size Text, specify: Primer
Device Size Text, specify: Single-Use Predosed Tip x 27
Weight: 0.35 Gram

Device Record Status

Public Device Record Key: 136eb0c6-ccb3-4600-9d49-f99121cb8ee4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016