Catalog Number

206150

Brand Name

AccuFill ® PreFill

Version/Model Number

206150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182107,K190814

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

3ef2c6ce-be27-4cb8-bd19-95bfdb1bcda7

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-