Syringe LL, W/BioCare Safety Needle - Disposable 3cc Syringe LL, W/BioGuard Safety - BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Duns Number:065762392

Device Description: Disposable 3cc Syringe LL, W/BioGuard Safety Needle 23G x 1"

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More Product Details

Catalog Number

BIO-1055S

Brand Name

Syringe LL, W/BioCare Safety Needle

Version/Model Number

BIO-1055S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

40020089-b28f-42d7-a4eb-4ddb771edd50

Public Version Date

May 06, 2021

Public Version Number

5

DI Record Publish Date

October 08, 2019

Additional Identifiers

Package DI Number

20858835007152

Quantity per Package

12

Contains DI Package

10858835007155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BIOTRONIX HEALTHCARE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 65