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Anastomark Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings

FDA UDI

Class II (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Anastomark Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings FDA UDI
Generic Name
Metallic coronary bypass marker, sterile FDA UDI
Device Name
Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings FDA UDI
Model / Reference
AMGM-BD FDA UDI
Description
Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings FDA UDI

Identifiers

Primary DI / UDI-DI
B040AMGMBD1 FDA UDI
FDA Product Code
DSY FDA UDI
GMDN Term
Metallic coronary bypass marker, sterile 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Metallic coronary bypass marker, sterile

Anastomark Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings by Genesee Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Metallic coronary bypass marker, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genesee Biomedical, Inc.

Sources (1)

  • FDA UDI 308ee92a-8cfe-4878-8def-05ca4165f66d 33 fields · synced Jun 8, 2026