Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Suturing needle, reusable FDA UDI
Device Name: wright fascia needle, curved shaft, 2.0 mm wide tip, ring handle, 5-1/8" (13.0 cm) FDA UDI
Model / Reference: OP7121-29 FDA UDI
Description: wright fascia needle, curved shaft, 2.0 mm wide tip, ring handle, 5-1/8" (13.0 cm) FDA UDI

Identifiers

Primary DI / UDI-DI: G586OP7121290 FDA UDI
FDA Product Code: GDL FDA UDI
GMDN Term: Suturing needle, reusable 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: Suturing needle, reusable

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

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Hayden Medical — Hayden Medical Inc · Class I
FENTEX — FENTEX medical GmbH · Class I
Hurd tonsil suture needle, right, 22 cm — Spiggle & Theis Medizintechnik GmbH · Class I
Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class II

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 dd185e10-e915-4690-85d7-08bd813f9430 33 fields · synced Jun 8, 2026