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Sml

FDA UDI

Class II (US FDA UDI)

by Selane Products, Inc.

Identity

Trade Name
SML FDA UDI
Generic Name
Tongue-training sleep-disordered breathing orthosis FDA UDI
Device Name
FULL BREATH-ALL ACRYLIC FDA UDI
Model / Reference
63603AAS FDA UDI
Description
FULL BREATH-ALL ACRYLIC FDA UDI

Identifiers

Primary DI / UDI-DI
D85463603AAS1 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Tongue-training sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tongue-training sleep-disordered breathing orthosis

Sml by Selane Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tongue-training sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Selane Products, Inc.

Sources (1)

  • FDA UDI bde66122-4287-4c72-b716-7f9390048ae7 33 fields · synced May 30, 2026