FDA.reportPublic FDA data

Eclipse Probe Cover

Primary DI
10855683006866
Brand
Eclipse Probe Cover
Company
PARKER LABORATORIES INC
Model
38-01-1
Device description
A soft disposable ultrasound probe cover
Published
2021-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953673000ECLIPSE PROBE COVERParker Laboratories, Inc.1996-03-14IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855683006866PrimaryGS10
00855683006869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085568300686610855683006866
00855683006869008556830068698556830068690855683006869

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface ultrasound imaging transducer coverA device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
973-276-9500customerservice@parkerlabs.com

Regulatory Flags#

DUNS number
002449593
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303410000012AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
00303410000029AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
00303410000036AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
00855683006579Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
10855683006576Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
20855683006023STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-01-42016-12-19
00855683006005STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-012016-12-19
10303410000019AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
10855683006965ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
20855683006962ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
10303410000033AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
10303410000026AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
00855683006739Timm Medical57-05-1447382019-11-11
10855683006347ECLIPSEPROBE COVER-LATEX FREE38-012016-12-19
10855683006354ECLIPSEPROBE COVER-LATEX FREE38-032016-12-19
10855683006361AQUAGELLUBRICATING GEL57-052016-12-19
00855683006371AQUAGELLUBRICATING GEL57-202016-12-19
10855683006545Ultradrape34-152023-09-18
10855683006910BrainScope99-1000-0042023-09-18
20855683006542Ultradrape34-152023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042542EV2-12SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042603CV1-8ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042849CA1-7SSAMSUNG MEDISON CO., LTD.IYO2025-10-13