stentfix OTSC System Set

Primary DI
04260206311706
Brand
stentfix OTSC System Set
Company
Ovesco Endoscopy Usa, Inc.
Model
stentfix
Catalog number
100.50
Device description
The stentfix 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 the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • 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
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183309000stentfix OTSC System SetOvesco Endoscopy AG2019-10-22PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260206311706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206311706042602063117064260206311706

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
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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