SCANLAN® Elliptical A/V Punch

FDA UDI

Class I (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name: SCANLAN® Elliptical A/V Punch FDA UDI
Generic Name: Aorta punch, single-use FDA UDI
Device Name: Single-Use Elliptical A/V Punch, Bulk Non-Sterile, 6.0mm x 2.0mm, 5-3/4"/14.5 cm, BNS, 5/pkg FDA UDI
Model / Reference: 1001-610B FDA UDI
Description: Single-Use Elliptical A/V Punch, Bulk Non-Sterile, 6.0mm x 2.0mm, 5-3/4"/14.5 cm, BNS, 5/pkg FDA UDI

Identifiers

Catalog Number: 1001-610B FDA UDI
Primary DI / UDI-DI: 00846159028904 FDA UDI
FDA Product Code: KDC FDA UDI
GMDN Term: Aorta punch, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Aorta punch, single-use

SCANLAN® Elliptical A/V Punch by Scanlan International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Aorta punch, single-use.

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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 I	Pending data

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Manufacturer

Manufacturer: Scanlan International Inc

Sources (1)

FDA UDI 58c47db1-31f8-4624-bd0f-60e41616c624 35 fields · synced May 30, 2026