FDA.reportPublic FDA data

Eclipse

Primary DI
00815430020296
Brand
Eclipse
Company
CLINICAL INNOVATIONS, LLC
Model
TR02
Catalog number
TR02-76EPS
Device description
Trial Insert
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

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
00815430020296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815430020296008154300202968154300202960815430020296

GMDN Terms#

Term, Definition table
TermDefinition
Faecal-incontinence vaginal insert trialA 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 for a short-term trial period (typically less than 2 weeks), and may be removed/replaced by the patient. This is a single-patient reusable device after appropriate cleaning/disinfection.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width76Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-668-6225cs@pelvalon.com

Regulatory Flags#

DUNS number
809524291
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
00814247020369traxi® Panniculus Retractor ExtenderPRS-10502016-09-01
30814247020346traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetaiPRS-05302016-09-01
30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
00814247020802traxi® Panniculus RetractorPRS-EVAL2016-09-22
00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
00814247020178Koala®IPC-5000E2016-09-01
00814247020741Goldtrace OneCNS0000082016-09-01
00814247020505Spiral Fetal Scalp ElectrodeCNS0000042016-09-01
00814247020512FSE CablesSBT-70102016-09-01
00814247020529FSE CablesSBT-70112016-09-01
00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01
00814247020598FSE CablesSBT-70192016-09-01
00814247021199FSEFSE-025S2023-09-27
10814247021196FSEFSE-025S2023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815430020616EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020623EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020630EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020647EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020654EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020661EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020678EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020685EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020692EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020708EclipseCLINICAL INNOVATIONS, LLCPJH2018-09-11
00815430020005EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020012EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020029EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020036EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020043EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020050EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020067EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020074EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020081EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020098EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020104EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020111EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020128EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020135EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020142EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020159EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020166EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020173EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020180EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23
00815430020197EclipseCLINICAL INNOVATIONS, LLCPJH2016-09-23