FDA.report

Eclipse

Primary DI
00815430020005
Brand
Eclipse
Company
PELVALON, INC.
Model
EC02
Catalog number
EC02-48RDS
Device description
Eclipse Insert
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PJHDynamic Rectal Control System

Product Code Classifications

CodeDeviceSpecialtyClass
PJHDynamic Rectal Control SystemGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K150558000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K150558000Eclipse SystemPelvalon, Inc.2015-11-12PJH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815430020005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815430020005008154300200058154300200050815430020005

GMDN Terms

TermDefinition
Faecal-incontinence vaginal insertA non-sterile inflatable device intended to be inserted into the vagina and inflated/deflated to assist bowel evacuation regulation, as a treatment for faecal incontinence. It consists of a semi-rigid base, an inflatable balloon, valve, and optional external tubing. The balloon is inflated to occlude the adjacent rectal lumen to prevent stool leakage, and deflated to allow normal passage of stool. The device is used therapeutically for over a long-term period (typically less than 1 year), and may be removed/replaced by the patient. This is a single-patient reusable device after appropriate cleaning/disinfection.

Device Sizes

TypeValueUnit
Width48Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
844-668-6225cs@pelvalon.com

Regulatory Flags

DUNS number
938517484
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00815430020401EclipseSZ02SZ02-48RD2016-09-23
00815430020418EclipseSZ02SZ02-51RD2016-09-23
00815430020425EclipseSZ02SZ02-51EP2016-09-23
00815430020432EclipseSZ02SZ02-57RD2016-09-23
00815430020449EclipseSZ02SZ02-57EP2016-09-23
00815430020456EclipseSZ02SZ02-64RD2016-09-23
00815430020463EclipseSZ02SZ02-64EP2016-09-23
00815430020470EclipseSZ02SZ02-70RD2016-09-23
00815430020487EclipseSZ02SZ02-70EP2016-09-23
00815430020494EclipseSZ02SZ02-76EP2016-09-23
00815430020012EclipseEC02EC02-51RDS2016-09-23
00815430020029EclipseEC02EC02-51EPS2016-09-23
00815430020036EclipseEC02EC02-57RDS2016-09-23
00815430020043EclipseEC02EC02-57EPS2016-09-23
00815430020050EclipseEC02EC02-64RDS2016-09-23
00815430020067EclipseEC02EC02-64EPS2016-09-23
00815430020074EclipseEC02EC02-70RDS2016-09-23
00815430020081EclipseEC02EC02-70EPS2016-09-23
00815430020098EclipseEC02EC02-76EPS2016-09-23
00815430020104EclipseEC02EC02-48RDR2016-09-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815430020616EclipsePELVALON, INC.PJH2018-09-11
00815430020623EclipsePELVALON, INC.PJH2018-09-11
00815430020630EclipsePELVALON, INC.PJH2018-09-11
00815430020647EclipsePELVALON, INC.PJH2018-09-11
00815430020654EclipsePELVALON, INC.PJH2018-09-11
00815430020661EclipsePELVALON, INC.PJH2018-09-11
00815430020678EclipsePELVALON, INC.PJH2018-09-11
00815430020685EclipsePELVALON, INC.PJH2018-09-11
00815430020692EclipsePELVALON, INC.PJH2018-09-11
00815430020708EclipsePELVALON, INC.PJH2018-09-11
00815430020012EclipsePELVALON, INC.PJH2016-09-23
00815430020029EclipsePELVALON, INC.PJH2016-09-23
00815430020036EclipsePELVALON, INC.PJH2016-09-23
00815430020043EclipsePELVALON, INC.PJH2016-09-23
00815430020050EclipsePELVALON, INC.PJH2016-09-23
00815430020067EclipsePELVALON, INC.PJH2016-09-23
00815430020074EclipsePELVALON, INC.PJH2016-09-23
00815430020081EclipsePELVALON, INC.PJH2016-09-23
00815430020098EclipsePELVALON, INC.PJH2016-09-23
00815430020104EclipsePELVALON, INC.PJH2016-09-23
00815430020111EclipsePELVALON, INC.PJH2016-09-23
00815430020128EclipsePELVALON, INC.PJH2016-09-23
00815430020135EclipsePELVALON, INC.PJH2016-09-23
00815430020142EclipsePELVALON, INC.PJH2016-09-23
00815430020159EclipsePELVALON, INC.PJH2016-09-23
00815430020166EclipsePELVALON, INC.PJH2016-09-23
00815430020173EclipsePELVALON, INC.PJH2016-09-23
00815430020180EclipsePELVALON, INC.PJH2016-09-23
00815430020197EclipsePELVALON, INC.PJH2016-09-23
00815430020203EclipsePELVALON, INC.PJH2016-09-23