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ACURA Stabilization System - Ratcheting quick connect T handle

FDA UDI

Class I (US FDA UDI)

by Indius Medical Technologies Private Limited

Identity

Trade Name
ACURA Stabilization System - Ratcheting quick connect T handle FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Ratcheting quick connect T handle FDA UDI
Model / Reference
IMDT.0014 FDA UDI
Description
Ratcheting quick connect T handle FDA UDI

Identifiers

Catalog Number
IMDT.0014 FDA UDI
Primary DI / UDI-DI
B922IMDT00140 FDA UDI
FDA Product Code
LXH 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 - Ratcheting quick connect T handle 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 af0fcb4c-e2e5-492b-b98e-b1ad3cade1b1 35 fields · synced May 30, 2026