FDA.reportPublic FDA data

ET Control Device V

Primary DI
04953170257124
Brand
ET Control Device V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
H-V100
Device description
H-V100 V-HOLDER
Published
2018-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFRDEVICE, LOCKING, FOR INTESTINAL CLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFRDevice, Locking, For Intestinal ClampGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170257124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170257124049531702571244953170257124

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece/electrode holder, reusableA device used to house or fix an active electrosurgical conducting unit (handpiece/pen with its electrode) when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. This device will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482000540Symmetry StoneASPEN SURGICAL PRODUCTS, INC.FFR2022-08-30
00192896105942Best Intestinal ClampSONTEC INSTRUMENTS, INC.FFR2020-12-21
04046963142476AESCULAPAesculap AGFFR2020-05-04
70885403275953V. MuellerSTERIS CORPORATIONFFR2020-04-15
70885403275960V. MuellerSTERIS CORPORATIONFFR2020-04-15
70885403275977V. MuellerSTERIS CORPORATIONFFR2020-04-15
00888118055101FORCEPSKLS-Martin L.P.FFR2018-09-26
00888118055118FORCEPSKLS-Martin L.P.FFR2018-09-26
00888118055125FORCEPSKLS-Martin L.P.FFR2018-09-26
00888118055132FORCEPSKLS-Martin L.P.FFR2018-09-26
00192896045446KNUTSON URETHROGRAPHY SETSONTEC INSTRUMENTS, INC.FFR2018-09-20
00192896072091HAYES INTESTINAL CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-19
10885403133473V. MuellerSTERIS CORPORATIONFFR2018-09-18
10885403133664V. MuellerSTERIS CORPORATIONFFR2018-09-18
10885403133701V. MuellerSTERIS CORPORATIONFFR2018-09-18
10885403133718V. MuellerSTERIS CORPORATIONFFR2018-09-18
00192896011571THORLAKSON LOWER OCCLUSIVE CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-18
10885403129155V. MuellerSTERIS CORPORATIONFFR2018-09-17
10885403129162V. MuellerSTERIS CORPORATIONFFR2018-09-17
10381780181231Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-09-12
M2741354401Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-09-12
00192896011502FEHLAND SIGMOID ANASTOMOSIS CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011519RESANO SIGMOID ANASTOMOSIS FORCEPS SONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011526HAYES INTESTINAL CLAMP SONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011540MIKULICZ CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011564THORLAKSON LOWER OCCLUSIVE CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011533BEST INTESTINAL CLAMP SONTEC INSTRUMENTS, INC.FFR2018-09-11
10885403050770V. MuellerSTERIS CORPORATIONFFR2018-08-30
10381780404385Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-05-03
M274X272831Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-05-03