OTSC System Set

Primary DI
04260206311676
Brand
OTSC System Set
Company
Ovesco Endoscopy Usa, Inc.
Model
12/3 t - 220
Catalog number
100.29
Device description
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
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101428000OTSC (OVER-THE SCOPE-CLIP) SYSTEM SETOvesco Endoscopy AG2010-12-01PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260206311676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206311676042602063116764260206311676

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, long-term, non-bioabsorbableA non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+19196519449customerservice@ovesco-usa.com

Regulatory Flags#

DUNS number
969139760
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260206311515mini OTSC System Setmini/6 a100.012024-09-13
04260206311522mini OTSC System Setmini/6 t100.022024-09-13
04260206311706stentfix OTSC System Setstentfix100.502024-09-13
04260206311539OTSC System Set11/3 a100.032024-09-10
04260206311546OTSC System Set11/3 t100.042024-09-10
04260206311553OTSC System Set12/3 a100.052024-09-10
04260206311560OTSC System Set12/3 t100.062024-09-10
04260206311577OTSC System Set14/3 a100.072024-09-10
04260206311584OTSC System Set14/3 t100.082024-09-10
04260206311591OTSC System Set11/6 a100.092024-09-10
04260206311607OTSC System Set11/6 t100.102024-09-10
04260206311614OTSC System Set12/6 a100.112024-09-10
04260206311621OTSC System Set12/6 t100.122024-09-10
04260206311638OTSC System Set14/6 a100.132024-09-10
04260206311645OTSC System Set14/6 t100.142024-09-10
04260206311652OTSC System Set12/6 gc100.272024-09-10
04260206311669OTSC System Set12/3 a - 220100.282024-09-10
04260206311683OTSC System Set12/6 a - 220100.302024-09-10
04260206311690OTSC System Set12/6 t - 220100.312024-09-10

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