Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Surgical instrument track identification tape FDA UDI
Device Name: instrument id roll tape, withstands repeated sterilization cycles, latex-free, 1/8" width x 250" total length, red FDA UDI
Model / Reference: 9913-18 FDA UDI
Description: instrument id roll tape, withstands repeated sterilization cycles, latex-free, 1/8" width x 250" total length, red FDA UDI

Identifiers

Catalog Number: 9913-18 FDA UDI
Primary DI / UDI-DI: G5869913180 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Surgical instrument track identification tape FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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

Category: Surgical instrument track identification tape

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

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Also classified as Surgical instrument track identification tape.

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ColorTrack® Identification Sheet Tape — Aspen Surgical Products, Inc. · Class I
Sklar — Sklar Corporation · Class I
Code Rings — Pulpdent Corporation · Class I
ColorTrack® Identification Sheet Tape — Aspen Surgical Products, Inc. · Class I
ColorTrack® Identification Sheet Tape — Aspen Surgical Products, 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 I	Pending data

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Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI b32994b0-db69-4c2a-8fec-aea8326ebdcc 35 fields · synced May 30, 2026