Forsure

FDA UDI

Class II (US FDA UDI)

by Forsure Medical Products Llc

Identity

Trade Name: Forsure FDA UDI
Generic Name: Hair extraction punch FDA UDI
Device Name: A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device. FDA UDI
Model / Reference: 11100050 FDA UDI
Description: A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device. FDA UDI

Identifiers

Catalog Number: 11100050 FDA UDI
Primary DI / UDI-DI: 00815123011372 FDA UDI
510(k) Number: K042684 FDA UDI
FDA Product Code: BTO FDA UDI
GMDN Term: Hair extraction punch FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5800 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

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 5.0 Millimeter FDA UDI

Category: Hair extraction punch

Forsure by Forsure Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Forsure Medical Products Llc

Sources (1)

FDA UDI 4c0c87c8-6100-455e-ad04-4bba0898e0da 37 fields · synced May 30, 2026