FDA.reportPublic FDA data

ESI

Primary DI
B3961501940
Brand
ESI
Company
FTT MEDICAL, INC.
Model
15-0194
Device description
BUIE-HIRSCHMAN ANOSCOPE, LARGE. ACMI FITTING.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FERAnoscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3961501940PrimaryHIBCC0

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
B3961501980ESI15-01982016-09-16
B3961502700ESI15-02702016-09-16
B396150270NL0ESI15-0270NL2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937027594AnoSPECCoopersurgical, Inc.FER2026-08-05
00888937027600AnoSPECCoopersurgical, Inc.FER2026-08-05
00888937027617AnoSPECCoopersurgical, Inc.FER2026-08-05
05060937770013SleeveLUX 24 Anoscope/ProctoscopeHaemoband SurgicalFER2026-04-28
05060937770020SleeveLUX 16 Anoscope/ProctoscopeHaemoband SurgicalFER2026-04-28
08033638802861Self-light anoscopesSAPI MED SPAFER2026-02-06
08033638802878Self-light anoscopesSAPI MED SPAFER2026-02-06
00860012876808Air AssistGASTRO CONCEPTS LLCFER2025-03-17
08051887044719THD N-Ano anoscopesTHD SPAFER2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044771THD N-ano anoscopeTHD SPAFER2025-03-14
18051887044730THD N-Ano anoscopeTHD SPAFER2025-03-14
18051887044754THD N-Ano AnoscopeTHD SPAFER2025-03-14
08033638801192AdaptorSAPI MED SPAFER2023-08-02
08033638800430Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800478Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800485Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801352EpoflierSAPI MED SPAFER2023-07-27
08033638802885Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800447Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638803585Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801260Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801369EpoflierSAPI MED SPAFER2023-07-27
08033638802892Self-light anoscopesSAPI MED SPAFER2023-07-27
00732094007657Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-27
00732094239331Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-25
04053755200436INSTRUMENT HEAD FOR UNISPEC TUBESHeine Optotechnik GmbH & Co. KGFER2023-01-11
00732094007626Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-05-07
00732094128208Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-05-07