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Nex-D2

FDA UDI

Class I (US FDA UDI)

by Next Orthosurgical

Identity

Trade Name
Nex-D2 FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
SILICONE AXIAL HANDLE, LARGE, RATCHET 1/4 SQUARE, CANULATED FDA UDI
Model / Reference
FAACAAA000000 FDA UDI
Description
SILICONE AXIAL HANDLE, LARGE, RATCHET 1/4 SQUARE, CANULATED FDA UDI

Identifiers

Catalog Number
FAACAAA000000 FDA UDI
Primary DI / UDI-DI
00840314120991 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting 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

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

Category: Surgical instrument handle, non-torque-limiting

Nex-D2 by Next Orthosurgical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Next Orthosurgical

Sources (1)

  • FDA UDI cd6437f4-cc7b-4201-8786-9357489f4bbb 35 fields · synced May 31, 2026