Mini Dilator Set 1.0, 1.5, 2.0, 2.5 &3.0mm

FDA UDI

Class I (US FDA UDI)

by Biopsy Fine Cut Instruments

Identity

Trade Name: MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM FDA UDI
Generic Name: Urethral sound, reusable FDA UDI
Device Name: MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM FDA UDI
Model / Reference: DL003 FDA UDI
Description: MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM FDA UDI

Identifiers

Catalog Number: DL003 FDA UDI
Primary DI / UDI-DI: G422DL0030 FDA UDI
FDA Product Code: KCF FDA UDI
GMDN Term: Urethral sound, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Urethral sound, reusable

Mini Dilator Set 1.0, 1.5, 2.0, 2.5 &3.0mm by Biopsy Fine Cut Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Biopsy Fine Cut Instruments

Sources (1)

FDA UDI fa4b2e19-003b-4f0a-a0d0-5b643ef602db 34 fields · synced May 30, 2026