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Lf

FDA UDI

Class II (US FDA UDI)

by Liebel-Flarsheim Company, LLC

Identity

Trade Name
LF FDA UDI
Generic Name
Angiographic syringe FDA UDI
Device Name
Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena FDA UDI
Model / Reference
900103P FDA UDI
Description
Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena FDA UDI

Identifiers

Primary DI / UDI-DI
10746190004271 FDA UDI
510(k) Number
K963071 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Angiographic syringe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 150 Milliliter FDA UDI
Pressure — 1200 Pound per Square Inch FDA UDI
Pressure — 8273 KiloPascal FDA UDI

Lf by Liebel-Flarsheim Company, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K963071 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Liebel-Flarsheim Company, LLC

Sources (1)

  • FDA UDI 58d86cfa-9ee8-4605-825d-f4d2e81cc555 36 fields · synced Jun 1, 2026