Reloading Unit for Linear Stapler

FDA UDI

Class II (US FDA UDI)

by B. J. ZH. F. Panther Medical Equipment Co., Ltd.

Identity

Trade Name: Reloading Unit for Linear Stapler FDA UDI
Generic Name: Open-surgery manual linear stapler, single-use FDA UDI
Model / Reference: (FLSL)H3.5E FDA UDI

Identifiers

Primary DI / UDI-DI: 06939282439175 FDA UDI
FDA Product Code: GDW FDA UDI
GMDN Term: Open-surgery manual linear stapler, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Open-surgery manual linear stapler, single-use

Reloading Unit for Linear Stapler by B. J. ZH. F. Panther Medical Equipment Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery manual linear stapler, single-use.

Single Use Linear Staplers — Victor Medical Instruments Co., Ltd. · Class IIb
Single Use Linear Staplers — Victor Medical Instruments Co., Ltd. · Class IIb
ETHICON SECURESTRAP — Ethicon Inc. · Class II
TA — Covidien LP · Class II
PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
Single Use Reloadable Linear Cutter Stapler and Reloads — Suzhou Lantex Medical Technology Company Limited · Class IIb

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 II	Pending data

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Manufacturer

Manufacturer: B. J. ZH. F. Panther Medical Equipment Co., Ltd.

Sources (1)

FDA UDI c67e0f5e-94d8-43ad-9813-5248b85eb49a 32 fields · synced Jun 8, 2026