VATS Geissendorfer Dissector - VATS Geissendorfer Dissector With Ratchet - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: VATS Geissendorfer Dissector With Ratchet Serrated Jaw Titanium

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More Product Details

Catalog Number

-

Brand Name

VATS Geissendorfer Dissector

Version/Model Number

2601-934

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

-

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

ddf35643-5e5c-4847-9e7f-81132c9cf141

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

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