Novo Surgical

FDA UDI

Class II (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: leyla brain retractors accessories, for mounting retractor to the operating table, rigid holding arm FDA UDI
Model / Reference: N6860-52 FDA UDI
Description: leyla brain retractors accessories, for mounting retractor to the operating table, rigid holding arm FDA UDI

Identifiers

Primary DI / UDI-DI: 00842331119293 FDA UDI
FDA Product Code: GZT FDA UDI
GMDN Term: Self-retaining surgical retractor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4800 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

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

Category: Self-retaining surgical retractor, reusable

Novo Surgical by Novo Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-retaining surgical retractor, reusable.

Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
Life Instruments — Life Instrument Corporation · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · Class I

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 II	Pending data

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Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI 48cfead3-5785-44c0-96e6-0a2de6fb1b2e 34 fields · synced May 30, 2026