FDA.reportPublic FDA data

OTSC Twin Grasper

Primary DI
04260206310228
Brand
OTSC Twin Grasper
Company
Ovesco Endoscopy AG
Model
165 cm
Catalog number
200.44
Device description
The OTSC Twin Grasper is one of the OTSC application aids • facilitates the approximation of gaping edges of a lesion before release of the OTSC clip • two jaws which can be opened separately (two grasping forceps in one device) • working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260206310228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206310228042602063102284260206310228

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49707196528160service@ovessco.com
+19196519449customerservice@ovesco-usa.com

Regulatory Flags#

DUNS number
344007369
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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04260206311935AWCduo184 cm200.57.062025-06-05
04260206310983BARS SetBARS Set100.602024-11-29
04260206310648Traction Polypectomy Snare220 cm200.55.102016-09-16
04260206311010colonic FTRD Set14200.702018-05-28
04260206311027Coag Dissector165 cm200.502018-07-05
04260206311034AqaNife1.5 mm200.53.012018-10-02
04260206311041AqaNife2.0 mm200.53.022018-10-02
04260206311058AqaNife2.5 mm200.53.032018-10-02
04260206311065AqaNife3.0 mm200.53.042018-10-02
04260206311072diagnostic FTRD Set13200.762018-10-02
04260206311003LiftUpLiftUp200.56.012022-08-22
04260206311355LiftUp KitLiftUp Kit200.56.022022-08-22
04260206311263BARS Anchor silver165 cm200.122022-11-22
04260206311270BARS Anchor black165 cm200.132022-11-22
04260206310143OTSC Anchor165 cm200.102016-09-16
04260206310235OTSC Twin Grasper220 cm200.452016-09-16
04260206310273OTSC Proctology Anchor38 cm200.612016-09-16
04260206310297OTSC Anchor 220tt220 cm200.112016-09-16

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