FDA.reportPublic FDA data

SOLOPATH

Primary DI
00852381011898
Brand
SOLOPATH
Company
ONSET MEDICAL CORPORATION
Model
SR-2025
Catalog number
SR-2025
Device description
SOLOPATH Re-collapsible Balloon Access System
Published
2017-03-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50852381011893PackageGS139Not in Commercial Distribution
00852381011898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085238101189350852381011893
00852381011898008523810118988523810118980852381011898

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length25Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid direct sunlight
Special Storage Condition, Specify00Do not store at extreme temperature and humidity
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
144431850
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852381004203SOLOPATHSTFI-1425STFI-14252016-09-24
00852381004210SOLOPATHSTFI-1435STFI-14352016-09-24
00852381004227SOLOPATHSTFI-1625STFI-16252016-09-24
00852381004234SOLOPATHSTFI-1635STFI-16352016-09-24
00852381004241SOLOPATHSTFI-1825STFI-18252016-09-24
00852381004258SOLOPATHSTFI-1835STFI-18352016-09-24
00852381004265SOLOPATHSTFI-1925STFI-19252016-09-24
00852381004272SOLOPATHSTFI-1935STFI-19352016-09-24
00852381004302SOLOPATHSTFI-2125STFI-21252016-09-24
00852381004319SOLOPATHSTFI-2135STFI-21352016-09-24
00852381004340SOLOPATHSR-1925SR-19252016-09-24
00852381004357SOLOPATHSR-1935SR-19352016-09-24
00852381004388SOLOPATHSR-2225SR-22252016-09-24
00852381004395SOLOPATHSR-2235SR-22352016-09-24
00852381004401SOLOPATHSR-2425SR-24252016-09-24
00852381004418SOLOPATHSR-2435SR-24352016-09-24
00852381011904SOLOPATHSR-2035SR-20352017-03-13
50852381004208SOLOPATHSTFI-1425STFI-14252016-09-24
50852381004215SOLOPATHSTFI-1435STFI-14352016-09-24
50852381004222SOLOPATHSTFI-1625STFI-16252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27