FDA.reportPublic FDA data

VascuTape Radiopaque Tape

Primary DI
00840663100385
Brand
VascuTape Radiopaque Tape
Company
Lemaitre Vascular, Inc.
Model
1108-20
Catalog number
1108-20
Device description
Glow 'N Tell 55cm 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
00840663100385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663100385008406631003858406631003850840663100385

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
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18
00840663110377AlboGraft Polyester Vascular Graft ATC6038ATC60382021-06-18
00840663110384AlboGraft Polyester Vascular Graft ATC1206ATC12062021-06-18
00840663102815AlboGraft Polyester Vascular GraftAMC1506AMC15062015-07-30
00840663102839AlboGraft Polyester Vascular Graft AMC4006AMC40062015-10-16
00840663102846AlboGraft Polyester Vascular GraftAMC6006AMC60062015-10-16
00840663102853AlboGraft Polyester Vascular GraftAMC1006AMC10062015-10-16
00840663102860AlboGraft Polyester Vascular GraftAMC4007AMC40072015-10-16
00840663102877AlboGraft Polyester Vascular GraftAMC1508AMC15082015-10-16
00840663102884AlboGraft Polyester Vascular GraftAMC3008AMC30082015-10-16
00840663102891AlboGraft Polyester Vascular Graft AMC4008AMC40082015-10-16
00840663102907AlboGraft Polyester Vascular Graft AMC6007AMC60072015-10-16
00840663102914AlboGraft Polyester Vascular Graft AMC6008AMC60082015-10-16
00840663102921AlboGraft Polyester Vascular Graft AMC1008AMC10082015-10-16
00840663102938AlboGraft Polyester Vascular Graft AMC1510AMC15102015-10-16
00840663102945AlboGraft Polyester Vascular Graft AMC3010AMC30102015-10-16
00840663102952AlboGraft Polyester Vascular Graft AMC4010AMC40102015-10-16
00840663102969AlboGraft Polyester Vascular Graft AMC6010AMC60102015-10-16
00840663102976AlboGraft Polyester Vascular Graft AMC1010AMC10102015-10-16
00840663102983AlboGraft Polyester Vascular Graft AMC1512AMC15122015-10-16

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
00840663100330VascuTape 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
00840663100392VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100408VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30