OTSC System Set - The OTSC System Set consists of a clip preloaded - Ovesco Endoscopy AG

Duns Number:344007369

Device Description: The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel a The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

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More Product Details

Catalog Number

100.03

Brand Name

OTSC System Set

Version/Model Number

11/3 a

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

Yes

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

K101428

Product Code Details

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Device Record Status

Public Device Record Key

a8dbea2f-2f51-402e-884e-48a8f4c8711e

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

September 18, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OVESCO ENDOSCOPY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 61