Oral Swabsticks, Unflavored

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Oral Swabsticks, Unflavored FDA UDI
Generic Name: Oral care swab FDA UDI
Model / Reference: 1220 FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784122038 FDA UDI
FDA Product Code: KXF FDA UDI
GMDN Term: Oral care swab FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6025 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

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Oral care swab

Oral Swabsticks, Unflavored by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral care swab.

Q-Care — SAGE PRODUCTS LLC · Class I
Q-Care — SAGE PRODUCTS LLC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
Toothette Oral Care — SAGE PRODUCTS LLC · Class II
Q-Care — SAGE PRODUCTS LLC · Class I
Q-Care — SAGE PRODUCTS LLC · Class II
Sage — SAGE PRODUCTS LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI fae6ed71-7c40-451d-9bba-df11ca0ed00e 32 fields · synced May 30, 2026