MICRO VEIN CLAMP PAIR - MICRO VEIN CLAMP PAIR WITH APPROXIMATOR BAR - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: MICRO VEIN CLAMP PAIR WITH APPROXIMATOR BAR

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More Product Details

Catalog Number

-

Brand Name

MICRO VEIN CLAMP PAIR

Version/Model Number

2100-ABB-22V

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

K092544

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

44de774b-24d7-4d9f-ba93-7413d337a67b

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

August 24, 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