SCANLAN® A/C Locator® graft marker

FDA UDI

Class II (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name: SCANLAN® A/C Locator® graft marker FDA UDI
Generic Name: Polymeric coronary bypass marker FDA UDI
Device Name: U-shaped style, silicone (1 per sterile pkg) FDA UDI
Model / Reference: 1001-83 FDA UDI
Description: U-shaped style, silicone (1 per sterile pkg) FDA UDI

Identifiers

Catalog Number: 1001-83 FDA UDI
Primary DI / UDI-DI: 00846159001037 FDA UDI
FDA Product Code: MAB FDA UDI
GMDN Term: Polymeric coronary bypass marker FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Polymeric coronary bypass marker

SCANLAN® A/C Locator® graft marker by Scanlan International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric coronary bypass marker.

Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal — GENESEE BIOMEDICAL, INC. · Class II
Voss Coronary Bypass Sterile Marker — VM CARDIO VASCULAR, INC. · Class II
Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal — GENESEE BIOMEDICAL, INC. · Class II
Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal — GENESEE BIOMEDICAL, INC. · Class II
Voss Non-Sterile Coronary Bypass Graft Marker — VM CARDIO VASCULAR, INC. · Class II
Scanlan® RADIOMARK® graft markers — SCANLAN INTERNATIONAL INC · Class II
Scanlan® A/C LOCATOR® graft markers — SCANLAN INTERNATIONAL INC · Class II
Scanlan® RADIOMARK® graft markers — SCANLAN INTERNATIONAL INC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Scanlan International Inc

Sources (1)

FDA UDI 11bc2254-09a3-42cc-990c-0f757fb74687 35 fields · synced May 30, 2026