Tranquil-L™

FDA UDI

Class I (US FDA UDI)

by Nexus Spine, L.l.c.

Identity

Trade Name: Tranquil-L™ FDA UDI
Generic Name: Orthopaedic surgical distractor, internal FDA UDI
Device Name: 6 mm Small Hudson Distractor FDA UDI
Model / Reference: 822939 FDA UDI
Description: 6 mm Small Hudson Distractor FDA UDI

Identifiers

Primary DI / UDI-DI: B6788229390 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic surgical distractor, internal 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 6 Millimeter FDA UDI

Category: Orthopaedic surgical distractor, internal

Tranquil-L™ by Nexus Spine, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Nexus Spine, L.l.c.

Sources (1)

FDA UDI 6f96887b-4d10-4feb-b8e0-f060060bcad6 34 fields · synced May 30, 2026