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AROSuture Sterile

FDA UDI

Class II (US FDA UDI)

by Aros Surgical Instruments Corporation

Identity

Trade Name
AROSuture Sterile FDA UDI
Generic Name
Vascular clamp, single-use FDA UDI
Device Name
AROSuture-Sterile 4-0, 3/8 circle, 19mm, Spatula reverse cutting, 18 inches, Box/12 FDA UDI
Model / Reference
SP19A04N-45 FDA UDI
Description
AROSuture-Sterile 4-0, 3/8 circle, 19mm, Spatula reverse cutting, 18 inches, Box/12 FDA UDI

Identifiers

Catalog Number
SP19A04N-45 FDA UDI
Primary DI / UDI-DI
10818245020571 FDA UDI
FDA Product Code
GAR FDA UDI
GMDN Term
Vascular clamp, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Vascular clamp, single-use

AROSuture Sterile by Aros Surgical Instruments Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular clamp, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aros Surgical Instruments Corporation

Sources (1)

  • FDA UDI 8efaac83-9171-419a-88e5-279363fd10a7 36 fields · synced Jun 8, 2026