Bent Needle Tips - Bent Needle Tips; 22 Gauge - Kerr Corporation

Duns Number:199354556

Device Description: Bent Needle Tips; 22 Gauge

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More Product Details

Catalog Number

-

Brand Name

Bent Needle Tips

Version/Model Number

T26B

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)

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

EID

Product Code Name

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Device Record Status

Public Device Record Key

4dce1829-839d-46ba-bd57-b1a94a1e9f36

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KERR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 595
U Unclassified 5