FDA.reportPublic FDA data

Vein Pick

Primary DI
40836559009250
Brand
Vein Pick
Company
Oscor Inc.
Model
VP52Y
Catalog number
VP52Y
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
K024053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024053000PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBOscor, Inc.2003-01-31DTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40836559009250PrimaryGS10
00836559009245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4083655900925040836559009250
00836559009245008365590092458365590092450836559009245

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
Length45Millimeter

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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00885672009786Introducer Kit for Impella®0052-30210052-30212019-09-24
00885672009793Introducer Kit for Impella®0052-30250052-30252019-09-24
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00836559006770Adelante Peel-Away Introducer SetAP09016AP090162017-11-15
00836559006794Adelante Peel-Away Introducer SetAP10016AP100162017-11-15
00836559006800Adelante Peel-Away Introducer SetAP10516AP105162017-11-15
00836559007050Adelante SigmaASGAT110162017-12-07
10836559007385Adelante SigmaASG050102017-11-16
10836559007392Adelante SigmaASG060102017-11-16

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