FDA.reportPublic FDA data

Regulus Introducer Set with Hemostatic Valve

Primary DI
07640168110215
Brand
Regulus Introducer Set with Hemostatic Valve
Company
Oscor Inc.
Model
SYM-IS-003
Catalog number
SYM-IS-003
Device description
Introducer Set with Hemostatic Valve 6.3 mm
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140917000INTRODUCER, MODEL ADELANTE MAGNUMOscor, Inc.2014-07-09DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640168110215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640168110215076401681102157640168110215

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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
Device Size Text, specify0
Lumen/Inner Diameter6.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
727-937-2511sales@oscor.com

Regulatory Flags#

DUNS number
101835833
Device count
1
Lot or batch
true
Expiration date on label
true

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00885672013073Volante™VLT-14-71-25-S-NMVLT-14-71-25-S-NM2026-05-08
00885672013080DiRex™ Steerable SheathM004DSD100M004DSD1002026-03-31

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