EXEL 50-60ml Bulk Non-Sterile Syringe - 60CC SYR CATH TIP ECC 25/PK - Exel International

Duns Number:180572216

Device Description: 60CC SYR CATH TIP ECC 25/PK

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More Product Details

Catalog Number

26302

Brand Name

EXEL 50-60ml Bulk Non-Sterile Syringe

Version/Model Number

26302

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

K861153

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

928dfd53-425c-424a-b4fb-c7201e174ab1

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXEL INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 82