AccessGUDID - DEVICE: Bosworth Ultra Trim (H66809218081)

GUDID

Device Identifier (DI) Information

Brand Name: Bosworth Ultra Trim
Version or Model: 0921808
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0921808
Company Name: Harry J Bosworth Company

Primary DI Number: H66809218081
Issuing Agency: HIBCC
Commercial Distribution End Date: September 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 014769301 *Terms of Use

Device Description: Bis-Acryl C&B Cartridge, A3.5

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:	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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, 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

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Special Storage Condition, Specify: For best results, refrigerate for storage
Special Storage Condition, Specify: Keep out of direct sunlight
Special Storage Condition, Specify: Keep away from moisture

Clinically Relevant Size

[?]

Size Type Text
Weight: 76 Gram
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: 8ce86039-c182-4c06-bcfe-b731a2c65636
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: September 15, 2016