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Paradigm

FDA UDI

Class II (US FDA UDI)

by Proprio

Identity

Trade Name
Paradigm FDA UDI
Generic Name
Surgical optical-tracking spatial marker, reusable FDA UDI
Device Name
DRF L-Rod, 50 mm FDA UDI
Model / Reference
1200013 FDA UDI
Description
DRF L-Rod, 50 mm FDA UDI

Identifiers

Catalog Number
1200013 FDA UDI
Primary DI / UDI-DI
00850042604168 FDA UDI
510(k) Number
K243258 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Surgical optical-tracking spatial marker, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Surgical optical-tracking spatial marker, reusable

Paradigm by Proprio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical optical-tracking spatial marker, reusable.

Cleared under the same submission

K243258 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Proprio

Sources (1)

  • FDA UDI ed03a645-8297-4258-8968-aed5b0f3763b 36 fields · synced May 30, 2026