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Iops™

FDA UDI

Class II (US FDA UDI)

by Centerline Biomedical

Identity

Trade Name
IOPS™ FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
IOPS™ Tracking Pad 1 FDA UDI
Model / Reference
TP-1 FDA UDI
Description
IOPS™ Tracking Pad 1 FDA UDI

Identifiers

Catalog Number
TP-1 FDA UDI
Primary DI / UDI-DI
00843152103003 FDA UDI
510(k) Number
K190106 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic surgical navigation device tracking system

Iops™ by Centerline Biomedical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Cleared under the same submission

K190106 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 7726c4fc-e996-41d0-87b1-6c587f5e11f7 35 fields · synced May 30, 2026