“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: Surgical implant handling forceps FDA UDI
Device Name: T2 Long Arm Breaker FDA UDI
Model / Reference: TR2-3300 FDA UDI
Description: T2 Long Arm Breaker FDA UDI

Identifiers

Catalog Number: TR2-3300 FDA UDI
Primary DI / UDI-DI: 04719878787116 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical implant handling forceps 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

Category: Surgical implant handling forceps

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

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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 1430499f-7479-4d7a-b2c7-6723a55d7589 34 fields · synced May 31, 2026