DURRANI DORSAL VEIN COMPLEX LIGATION NEEDLE - DURRANI DORSAL VEIN COMPLEX LIGATION NEEDLE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: DURRANI DORSAL VEIN COMPLEX LIGATION NEEDLE

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More Product Details

Catalog Number

515-505

Brand Name

DURRANI DORSAL VEIN COMPLEX LIGATION NEEDLE

Version/Model Number

515-505

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

-

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

GDM

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, REUSABLE

Device Record Status

Public Device Record Key

06c22df9-a6f6-4645-bc13-f84a1e23d079

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

September 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414