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IOPS Viewpoint

FDA UDI

Class II (US FDA UDI)

by Centerline Biomedical

Identity

Trade Name
IOPS Viewpoint FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Simple Curve Catheter, 75 cm FDA UDI
Model / Reference
C00751 FDA UDI
Description
Simple Curve Catheter, 75 cm FDA UDI

Identifiers

Catalog Number
C00751 FDA UDI
Primary DI / UDI-DI
00843152101061 FDA UDI
510(k) Number
K241243 FDA UDI
FDA Product Code
DQK FDA UDI
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
870.1250 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 75 Centimeter FDA UDI
Catheter Length — 85 Centimeter FDA UDI
Catheter Gauge — 6 French FDA UDI
Catheter Inner Diameter — 0.035 Inch FDA UDI

Category: Vascular guide-catheter, single-use

IOPS Viewpoint by Centerline Biomedical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Cleared under the same submission

K241243 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centerline Biomedical

Sources (1)

  • FDA UDI 82d6ce15-fbfb-4977-b299-e2be917e934d 36 fields · synced Jun 8, 2026