FDA.reportPublic FDA data

VascuTape Radiopaque Tape

Primary DI
00840663100330
Brand
VascuTape Radiopaque Tape
Company
Lemaitre Vascular, Inc.
Model
1100-20
Catalog number
1100-20
Device description
Glow 'N Tell 30cm Tape (20 Strips)
Published
2015-06-30
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
KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932184000STERILE LEMAITRE GLOW 'N TELL TAPEVascutech, Inc.1993-07-22KFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663100330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663100330008406631003308406631003300840663100330

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film rulerA device used in radiology to superimpose accurate measurements of length (i.e., inches or millimetres) onto an x-ray film so that these measurements remain as a permanent feature of that x-ray against the anatomical structure that has been captured. It is made of x-ray translucent material (e.g., plastic) whilst the graduations are not translucent and therefore show on the exposed x-ray film. This is a reusable 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D2486054301MIRABRUSH YELLOW POINTEDHAGER WORLDWIDE, INC.KFX2023-08-04
D2486054311MIRABRUSH BLUE STRAIGHTHAGER WORLDWIDE, INC.KFX2023-08-04
D2486054300MIRABRUSH YELLOW POINTEDHAGER WORLDWIDE, INC.KFX2023-08-04
D2486054310MIRABRUSH BLUE STRAIGHTHAGER WORLDWIDE, INC.KFX2023-08-04
00840663108916YES TapeLemaitre Vascular, Inc.KFX2021-06-18
00840663110339Vesper Custom TapeLemaitre Vascular, Inc.KFX2021-06-18
00840663100323VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100347VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100354VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100361VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100378VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100385VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100392VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100408VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30