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Graft Sizers

FDA UDI

Class II (US FDA UDI)

by Intervascular, Inc.

Identity

Trade Name
GRAFT SIZERS FDA UDI
Generic Name
Open-surgery blood vessel sizer, single-use FDA UDI
Device Name
Graft Sizers size 05 mm - 24 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200201. FDA UDI
Model / Reference
Size 05 mm - 24 mm FDA UDI
Description
Graft Sizers size 05 mm - 24 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200201. FDA UDI

Identifiers

Primary DI / UDI-DI
00384401016502 FDA UDI
510(k) Number
K854431 FDA UDI
FDA Product Code
DSY FDA UDI
GMDN Term
Open-surgery blood vessel sizer, single-use 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Open-surgery blood vessel sizer, single-use

Graft Sizers by Intervascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery blood vessel sizer, single-use.

Cleared under the same submission

K854431 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intervascular, Inc.

Sources (1)

  • FDA UDI 1c086bcf-5c67-43aa-a791-dd5f1cfa9217 37 fields · synced May 30, 2026