FDA.reportPublic FDA data

Eclipse

Primary DI
00815430020487
Brand
Eclipse
Company
CLINICAL INNOVATIONS, LLC
Model
SZ02
Catalog number
SZ02-70EP
Device description
Sizer
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
00815430020487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815430020487008154300204878154300204870815430020487

GMDN Terms#

Term, Definition table
TermDefinition
Faecal-incontinence vaginal insert sizerA non-sterile device intended to be used to determine the appropriate size of a faecal-incontinence vaginal insert for a particular patient. It is in the form of a semi-rigid ring that is inserted into the vagina as a guide to the size of the trial/final insert. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device for multi-patient use after appropriate cleaning/disinfection.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length76Millimeter
Width70Millimeter

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