Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Vaginal dilator FDA UDI
Device Name: DILATOR, SILICONE, VAGINAL SET, LARGE FDA UDI
Model / Reference: MDS6303001 FDA UDI
Description: DILATOR, SILICONE, VAGINAL SET, LARGE FDA UDI

Identifiers

Catalog Number: MDS6303001 FDA UDI
Primary DI / UDI-DI: 10888277632110 FDA UDI
FDA Product Code: HDX FDA UDI
GMDN Term: Vaginal dilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.3900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Category: Vaginal dilator

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal dilator.

Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
ELMED INCORPORATED — ELMED INCORPORATED · Class I
DILATOR — KLS-Martin L.P. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
ELMED INCORPORATED — ELMED INCORPORATED · Class I
GEN2 — SURGIX MEDICAL LLC · Class I

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: Medline Industries, Inc.

Sources (1)

FDA UDI 6c9650a7-5bfc-402d-960f-501923e948d5 35 fields · synced May 30, 2026