SURGYCO - Surgyco Hypodermic Needle Single Lumen 27G x 1/2" - Surgyco LLC

Duns Number:118768538

Device Description: Surgyco Hypodermic Needle Single Lumen 27G x 1/2"

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More Product Details

Catalog Number

-

Brand Name

SURGYCO

Version/Model Number

SRN02735

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

319a5afd-43cc-497d-acc9-83e01302ff15

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Additional Identifiers

Package DI Number

20850044799149

Quantity per Package

10000

Contains DI Package

10850044799142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SURGYCO LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1