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Ctm-400

FDA UDI

Class I (US FDA UDI)

by Ivy Biomedical Systems, Inc.

Identity

Trade Name
CTM-400 FDA UDI
Generic Name
X-ray system synchronizer FDA UDI
Device Name
Cardiac Gating Module & Accessory Kit FDA UDI
Model / Reference
3310-01-15 FDA UDI
Description
Cardiac Gating Module & Accessory Kit FDA UDI

Identifiers

Catalog Number
3310-01-15 FDA UDI
Primary DI / UDI-DI
00816396020795 FDA UDI
FDA Product Code
IXO FDA UDI
GMDN Term
X-ray system synchronizer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1970 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Weight — 1.25 Pound FDA UDI
Depth — 11 Inch FDA UDI
Width — 4 Inch FDA UDI
Height — 2 Inch FDA UDI

Category: X-ray system synchronizer

Ctm-400 by Ivy Biomedical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray system synchronizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA UDI ca3e92a5-ddba-4c31-ae56-6a8ecbee2bb6 36 fields · synced Jun 9, 2026