“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)

FDA UDI

Class I (US FDA UDI)

by Paonan Biotech Co., Ltd.

Identity

Trade Name: “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: T2 Cannulated Tap 5.5 mm FDA UDI
Model / Reference: 422-0105 FDA UDI
Description: T2 Cannulated Tap 5.5 mm FDA UDI

Identifiers

Catalog Number: 422-0105 FDA UDI
Primary DI / UDI-DI: 04719878786997 FDA UDI
FDA Product Code: HWX FDA UDI
GMDN Term: Bone tap, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.5 Millimeter FDA UDI

Category: Bone tap, reusable

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) by Paonan Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID

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Also classified as Bone tap, reusable.

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ReLine — Nuvasive, Inc. · Class I
Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · 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: Paonan Biotech Co., Ltd.

Sources (1)

FDA UDI ba56c619-efbd-494d-9b6a-5bb32ca15a88 35 fields · synced May 30, 2026