VATS DUVAL CLAMP - V.A.T.S. DUVAL CLAMP CURVED WITHOUT RATCHET 1 x 2 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: V.A.T.S. DUVAL CLAMP CURVED WITHOUT RATCHET 1 x 2 DEBAKEY JAW

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More Product Details

Catalog Number

-

Brand Name

VATS DUVAL CLAMP

Version/Model Number

2100-825A

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

K152400

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

5351bea9-9b81-43cd-836f-bb2fa3a48b7e

Public Version Date

May 19, 2020

Public Version Number

1

DI Record Publish Date

May 11, 2020

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