PenBlade Safety Scalpel

FDA UDI

Class I (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name: PenBlade Safety Scalpel FDA UDI
Generic Name: Scalpel, single-use FDA UDI
Device Name: The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position. FDA UDI
Model / Reference: #10 Blade FDA UDI
Description: The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position. FDA UDI

Identifiers

Catalog Number: PB-M-10 FDA UDI
Primary DI / UDI-DI: 10853624005008 FDA UDI
FDA Product Code: GDX FDA UDI
GMDN Term: Scalpel, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Scalpel, single-use

The PenBlade Safety Scalpel is a high-quality, single-use scalpel designed for general surgery procedures. It features a unique mechanism to extend and retract a blade between an exposed and a retracted safe position, making it a reliable choice for surgeons and medical professionals. With its durable construction and comfortable handle, the PenBlade Safety Scalpel is ideal for use in various surgical settings.

Similar devices

Also classified as Scalpel, single-use.

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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: ZIEN Medical Technologies, LLC

Sources (1)

FDA UDI eb9477d1-f3ce-46d5-8913-7d1dade73cb8 34 fields · synced Sep 17, 2026