FDA.reportPublic FDA data

Eclipse

Primary DI
00815430020548
Brand
Eclipse
Company
PELVALON, INC.
Model
RR02
Catalog number
RR02-MedLo
Device description
Regulator
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJHDynamic Rectal Control System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJHDynamic Rectal Control SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150558000Eclipse SystemPelvalon, Inc.2015-11-12PJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815430020548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815430020548008154300205488154300205480815430020548

GMDN Terms#

Term, Definition table
TermDefinition
Faecal-incontinence vaginal insert pumpA manually-powered air pump designed to inflate/deflate a faecal-incontinence vaginal insert used to assist bowel evacuation regulation, as a treatment for faecal incontinence. It includes a replaceable regulator which determines the maximum pressure of the insert balloon. This is a single-patient reusable device after appropriate cleaning/disinfection.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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
00815430020005EclipseEC02EC02-48RDS2016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
00815430020005EclipsePELVALON, INC.PJH2016-09-23
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