FDA.reportPublic FDA data

Vein Pick

Primary DI
40836559009236
Brand
Vein Pick
Company
Oscor Inc.
Model
VP51B
Catalog number
VP51B
Device description
Vein Pick
Published
2017-11-27
Public version status
Update
Distribution status
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
DTBpermanent pacemaker Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020669000PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJBOscor, Inc.2002-03-28DTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40836559009236PrimaryGS10
00836559002031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4083655900923640836559009236
00836559002031008365590020318365590020310836559002031

GMDN Terms#

Term, Definition table
TermDefinition
Vein pickA small surgical instrument that is used to open an incision in a vein typically for the introduction of an implantable pacing lead (the electrode tip) into the vein. It is typically a long, hand-held instrument that tapers to a blunt point at its distal end and is typically made of plastic. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length110Millimeter

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
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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