FDA.reportPublic FDA data

ENSIZOR

Primary DI
M707ES26165
Brand
ENSIZOR
Company
SLATER ENDOSCOPY LLC
Model
ES26165
Catalog number
ES26165
Device description
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.
Published
2016-08-23
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
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M707ES261650PackageHIBCC1In Commercial Distribution
M707ES261651PackageHIBCC3In Commercial Distribution
M707ES26165PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, single-useA flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length165Centimeter
Outer Diameter2.6Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
305-889-3350jstarkey@slaterendoscopy.com
305-889-3350crslater@slaterendoscopy.com

Regulatory Flags#

DUNS number
090101258
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001219821ENSIZORES26235ES26235-12023-08-11
00860001219845ENSIZORES26165ES26165-12023-08-11
00860001219852ENSIZORES26165ES26165-12023-08-11
00860001219838ENSIZORES26235ES26235-12023-08-11
M707ES26235ENSIZORES26235ES262352016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14953170466165Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
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00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
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00860001219852ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219838ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
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