FDA.reportPublic FDA data

ESI

Primary DI
B396154013LC0
Brand
ESI
Company
FTT MEDICAL, INC.
Model
15-4013LC
Device description
REPLACEMENT LIGHT CARRIER ONLY FOR 4CM X 12CM INSULATED SALVATI PROCTOSCOPE. ACMI FITTING.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCFProctoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCFProctoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B396154013LC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Proctoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002212793
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B39615001700ESI15-001702016-09-16
B3961501500ESI15-01502016-09-16
B3961501520ESI15-01522016-09-16
B3961501540ESI15-01542016-09-16
B3961501580ESI15-01582016-09-16
B3961501590ESI15-01592016-09-16
B3961501710ESI15-01712016-09-16
B3961501720ESI15-01722016-09-16
B396150172O0ESI15-0172-O2016-09-16
B3961501730ESI15-01732016-09-16
B3961501740ESI15-01742016-09-16
B3961501750ESI15-01752016-09-16
B3961501800ESI15-01802016-09-16
B3961501820ESI15-01822016-09-16
B3961501840ESI15-01842016-09-16
B3961501900ESI15-01902016-09-16
B3961501920ESI15-01922016-09-16
B3961501940ESI15-01942016-09-16
B3961501980ESI15-01982016-09-16
B3961502700ESI15-02702016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551084724n.a.Karl Storz GmbH & Co. KGGCF2018-08-21
04048551265420n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265437n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265444n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265475n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265499n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265505n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314500n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314524n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314555n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551229378n.a.Karl Storz GmbH & Co. KGGCF2017-10-20
04048551083307n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083390RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083420RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083628RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083666RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083727TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083741TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083840n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083888n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083901n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083956n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083970n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083994n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084014TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084038TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084090TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084113TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084168n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084434n.a.Karl Storz GmbH & Co. KGGCF2016-09-23