mini OTSC System Set

Primary DI
04260206311515
Brand
mini OTSC System Set
Company
Ovesco Endoscopy Usa, Inc.
Model
mini/6 a
Catalog number
100.01
Device description
The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • 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
2024-09-13
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
04260206311515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206311515042602063115154260206311515

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
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
04260206311676OTSC System Set12/3 t - 220100.292024-09-10
04260206311683OTSC System Set12/6 a - 220100.302024-09-10
04260206311690OTSC System Set12/6 t - 220100.312024-09-10

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