Sage

FDA UDI

Class I (US FDA UDI)

by Sage Products Llc

Identity

Trade Name: Sage FDA UDI
Generic Name: Oral care kit, single-use FDA UDI
Device Name: Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis FDA UDI
Model / Reference: 9011 FDA UDI
Description: Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis FDA UDI

Identifiers

Catalog Number: 9011 FDA UDI
Primary DI / UDI-DI: 00618029850188 FDA UDI
FDA Product Code: MAC FDA UDI
NSB FDA UDI
KXF FDA UDI
EFW FDA UDI
GMDN Term: Oral care kit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4014 FDA UDI
872.6855 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

FDA UDI

Category: Basic manual toothbrush Oral care kit, single-use Oral care swab

Sage by Sage Products Llc — 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: Sage Products Llc

Sources (1)

FDA UDI 841fb2eb-8f31-4bfd-86cb-6354eeedd709 36 fields · synced Jun 8, 2026