AccessGUDID - DEVICE: Injectafil A2 Syringe Refill with Tips (00850194007381)

GUDID

Device Identifier (DI) Information

Brand Name: Injectafil A2 Syringe Refill with Tips
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 107-A2-Refill
Company Name: Vista Dental

Primary DI Number: 00850194007381
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036623932 *Terms of Use

Device Description: Injectafil A2 Syringe Refill with Tips

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?
16725	Self-cured dental restorative composite resin	A dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, self-polymerizable, organic resin matrix that is typically used to fill dental cavities or restore damaged dental tissue. It is typically a two-paste system (self-cured when put together) consisting basically of a dimethacrylate resin [(e.g., a bisphenol A and glycidylmethacrylate (BIS-GMA)]; the filler is usually made of glass, quartz, or ceramic. Typically, one paste contains an accelerator and the other a catalyst which polymerize a solid resin. This single-use product should match the colour of the original teeth for aesthetic reasons.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091647	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65ae27d9-bbf0-49b2-ab6d-035c56119353
Public Version Date: February 04, 2021
Public Version Number: 4
DI Record Publish Date: June 16, 2016