RIN-11-11, Component Two - Ranfac Injection Needle, F/G, SterileP/N 74343-01M - RANFAC CORP.

Duns Number:121622872

Device Description: Ranfac Injection Needle, F/G, SterileP/N 74343-01M

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More Product Details

Catalog Number

RIN-11-11

Brand Name

RIN-11-11, Component Two

Version/Model Number

11 Gauge x 11cm

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

FGY

Product Code Name

Cannula, Injection

Device Record Status

Public Device Record Key

08ad025d-e9db-41aa-9a79-5414c1d257af

Public Version Date

August 27, 2019

Public Version Number

1

DI Record Publish Date

August 19, 2019

Additional Identifiers

Package DI Number

10857878007863

Quantity per Package

1

Contains DI Package

00857878007866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack

"RANFAC CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 93