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ACURA Stabilization System - Ball Tip Probe

FDA UDI

Class I (US FDA UDI)

by Indius Medical Technologies Private Limited

Identity

Trade Name
ACURA Stabilization System - Ball Tip Probe FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Ball Tip Probe FDA UDI
Model / Reference
F004.0119 FDA UDI
Description
Ball Tip Probe FDA UDI

Identifiers

Catalog Number
F004.0119 FDA UDI
Primary DI / UDI-DI
B922F00401190 FDA UDI
FDA Product Code
HXB FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

FDA UDI

Lot / Batch Number

No

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

Category: Internal spinal fixation procedure kit, reusable

ACURA Stabilization System - Ball Tip Probe by Indius Medical Technologies Private Limited — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Indius Medical Technologies Private Limited

Sources (1)

  • FDA UDI de219117-4d63-449a-ae98-91a2cde354b0 35 fields · synced Jun 1, 2026