Angio-Seal

FDA UDI

Class III (US FDA UDI)

by Terumo Medical Corporation

Identity

Trade Name: ANGIO-SEAL FDA UDI
Generic Name: Femoral artery closure plug/patch, collagen FDA UDI
Device Name: ANGIO-SEAL VIP Vascular Closure Device FDA UDI
Model / Reference: 610131 FDA UDI
Description: ANGIO-SEAL VIP Vascular Closure Device FDA UDI

Identifiers

Catalog Number: 610131 FDA UDI
Primary DI / UDI-DI: 00389701011813 FDA UDI
FDA Product Code: MGB FDA UDI
GMDN Term: Femoral artery closure plug/patch, collagen FDA UDI

Classification

Device Class: Class III 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 8 French FDA UDI

Category: Femoral artery closure plug/patch, collagen

Angio-Seal by Terumo Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 III	Pending data

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Manufacturer

Manufacturer: Terumo Medical Corporation

Sources (1)

FDA UDI 602b01a8-8b01-4a11-af10-fdc5b2080d50 37 fields · synced May 31, 2026