VascuTape Radiopaque Tape

Basic Information

• Brand Name: VascuTape Radiopaque Tape
• Primary DI: 00840663100378
• Version / Model: 1102-50
• Catalog Number: 1102-50
• Company Name: Lemaitre Vascular, Inc.
• Labeler DUNS: 184805166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-30
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 6f64755f-6933-41ff-a53a-90d8c7472af0

Device Description

LeMaitre Stent Guide (50 Strips)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KFX	Assembly, Thigh/Knee/Shank/Ankle/Foot, External	Physical Medicine	890.3500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42303	X-ray film ruler	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663100378	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K932184	000