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Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical FDA UDI
Generic Name
Bone-coring punch, reusable FDA UDI
Device Name
spurling-kerrison rongeur, large handles, 15.0 mm opening, thin footplates, 90 degrees up, 2.0 mm bite, 7" (17.8 cm) FDA UDI
Model / Reference
N6816-43 FDA UDI
Description
spurling-kerrison rongeur, large handles, 15.0 mm opening, thin footplates, 90 degrees up, 2.0 mm bite, 7" (17.8 cm) FDA UDI

Identifiers

Catalog Number
N6816-43 FDA UDI
Primary DI / UDI-DI
G586N6816430 FDA UDI
FDA Product Code
HTX FDA UDI
GMDN Term
Bone-coring punch, 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

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

Category: Bone-coring punch, reusable

A comprehensive medical device directory listing for the Novo Surgical Bone-coring Punch, a reusable surgical instrument designed to cut out (core) sections of bone or a combination of bone and soft-tissue during surgery.

Similar devices

Also classified as Bone-coring punch, 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 e8c7aaeb-c81c-4640-b417-404297cd96c1 35 fields · synced Jul 21, 2026