AccessGUDID - DEVICE: Bosworth Pit & Fissure (H668092156S1)

GUDID

Device Identifier (DI) Information

Brand Name: Bosworth Pit & Fissure
Version or Model: 092156S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 092156S
Company Name: Harry J Bosworth Company

Primary DI Number: H668092156S1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014769301 *Terms of Use

Device Description: Pit & Fissure LC Sealant w Fluoride Sample

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:	Yes
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?
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER

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 0 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from moisture

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.2 Milliliter

Device Record Status

Public Device Record Key: 8fc47240-2f87-4627-bbea-c378dcc30447
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2016