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Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical Inc. FDA UDI
Generic Name
Myoma screw, reusable FDA UDI
Device Name
cloward style graft impactor, double-ended, 7/16" (11.0 mm) & 9/16" (14.0 mm) diameter, 8 3/4" (22.5 cm) FDA UDI
Model / Reference
N8831-25 FDA UDI
Description
cloward style graft impactor, double-ended, 7/16" (11.0 mm) & 9/16" (14.0 mm) diameter, 8 3/4" (22.5 cm) FDA UDI

Identifiers

Catalog Number
N8831-25 FDA UDI
Primary DI / UDI-DI
00842331144561 FDA UDI
FDA Product Code
HWA FDA UDI
GMDN Term
Myoma screw, reusable 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

Yes

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

Category: Myoma screw, reusable

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

Similar devices

Also classified as Myoma screw, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Surgical, Inc.

Sources (1)

  • FDA UDI ce254406-4d0f-44ba-a715-b3fb517fb87f 35 fields · synced Jun 1, 2026