FDA.reportPublic FDA data

SafeSept® Transseptal Guidewire

Primary DI
00891492002395
Brand
SafeSept® Transseptal Guidewire
Company
Oscor Inc.
Model
SS-135
Catalog number
SS-135
Device description
Transseptal Guidewire
Published
2017-11-27
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081986000SAFESEPT TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2008-11-14DRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00891492002395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00891492002395008914920023958914920023950891492002395

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal needle, single-useA device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length135Centimeter
Outer Diameter0.014Inch

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
+1(727)937-2511sales@oscor.com

Regulatory Flags#

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

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