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Tranquil-L™

FDA UDI

Class I (US FDA UDI)

by Nexus Spine, L.l.c.

Identity

Trade Name
Tranquil-L™ FDA UDI
Generic Name
Spinal rongeur FDA UDI
Device Name
Pituitary, Straight, 5mm FDA UDI
Model / Reference
823154 FDA UDI
Description
Pituitary, Straight, 5mm FDA UDI

Identifiers

Primary DI / UDI-DI
B6788231540 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Spinal rongeur 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

Dimensions & Sizes

Size
Width — 5 Millimeter FDA UDI

Category: Spinal rongeur

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

Similar devices

Also classified as Spinal rongeur.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexus Spine, L.l.c.

Sources (1)

  • FDA UDI c6982f07-a4bd-47aa-b5d4-7c44f5619353 34 fields · synced Jun 8, 2026