MICASEPT CLIP APPLIER - MICASEPT CLIP APPLIER FOR TITANIUM CLIPS SMALL - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: MICASEPT CLIP APPLIER FOR TITANIUM CLIPS SMALL

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More Product Details

Catalog Number

27932-25

Brand Name

MICASEPT CLIP APPLIER

Version/Model Number

27932-25

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

K002877

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

2a94b213-be9d-4174-a2d0-45d89c7568d0

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

August 15, 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