CooperSurgical, Inc. - 16 Gauge Tip, 1 1/2" Needle, Curved - Coopersurgical, Inc.

Duns Number:801895244

Device Description: 16 Gauge Tip, 1 1/2" Needle, Curved

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More Product Details

Catalog Number

-

Brand Name

CooperSurgical, Inc.

Version/Model Number

900106

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

-

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

K935010

Product Code Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

0b9cae38-98d3-411d-b00d-c639cc3b3f82

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOPERSURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 1471
3 A medical device with high risk that requires premarket approval 2