FDA.reportPublic FDA data

InvisiGrip Vein Stripper

Primary DI
00840663100415
Brand
InvisiGrip Vein Stripper
Company
Lemaitre Vascular, Inc.
Model
1500-01
Catalog number
1500-01
Device description
InvisiGrip Vein Stripper
Published
2015-06-30
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
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023688000LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPERLeMaitre Vascular, Inc.2003-01-30GAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663100415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663100415008406631004158406631004150840663100415

GMDN Terms#

Term, Definition table
TermDefinition
Vein stripper, single-useA sterile hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-221-2266xx@xx.xx

Regulatory Flags#

DUNS number
184805166
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663102297Eze-Sit Valvulotome94cmTIVK20302022-06-30
00840663100095Expandable LeMaitre Valvulotome1000-901000-902015-06-30
00840663100101Expandable LeMaitre Valvulotomee1000-90e1000-902015-06-30
00840663100118Expandable LeMaitre Valvulotome1000-951000-952015-06-30
00840663100132Over-the-Wire LeMaitre Valvulotome1005-001005-002015-06-30
00840663100149Over-the-Wire LeMaitre Valvulotomee1005-00e1005-002015-06-30
00840663100163Over-the-Wire LeMaitre Valvulotome1006-001006-002015-06-30
00840663100309Expandable LeMaitre Valvulotome1096-001096-002015-06-30
00840663106653HYDRO LeMaitre Valvulotome1009-001009-002015-06-30
00840663106660HYDRO LeMaitre Valvulotome1010-001010-002015-06-30
00840663106721Expandable LeMaitre Valvulotomee1096-00e1096-002015-07-15
00840663106820Hydro LeMaitre Valvulotomee1009-00e1009-002015-07-15
00840663106837Hydro LeMaitre Valvulotomee1010-00e1010-002015-07-15
00840663107315Retrograde LeMills Valvulotome1050-001050-002015-06-30
00840663107322Antegrade LeMills Valvulotome1050-011050-012015-06-30
00840663107339Antegrade and Retrograde LeMills Valvulotome1050-021050-022015-06-30
00840663107346Retrograde LeMills Valvulotomee1050-00e1050-002015-06-30
00840663107353Antegrade LeMills Valvulotomee1050-01e1050-012015-06-30
00840663107360Antegrade and Retrograde LeMills Valvulotomee1050-02e1050-022015-06-30
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18

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