Coeur

FDA UDI

Class II (US FDA UDI)

by Coeur, Inc.

Identity

Trade Name: Coeur FDA UDI
Generic Name: Angiographic syringe FDA UDI
Device Name: MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96" Y-Line, and 2 Spikes) FDA UDI
Model / Reference: C853-2201 FDA UDI
Description: MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96" Y-Line, and 2 Spikes) FDA UDI

Identifiers

Catalog Number: C853-2201 FDA UDI
Primary DI / UDI-DI: M297722010 FDA UDI
510(k) Number: K161471 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 115 Milliliter FDA UDI
Total Volume — 65 Milliliter FDA UDI
Length — 96 Inch FDA UDI

Category: Angiographic syringe

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

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Cleared under the same submission

K161471 also covers:

Coeur — Coeur, Inc.

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 II	Pending data

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Manufacturer

Manufacturer: Coeur, Inc.

Sources (1)

FDA UDI 5e30f73b-a66c-445f-961f-07fc08d01947 38 fields · synced Jun 8, 2026