← Back to catalogue

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-NO SNORE / ACRYLIC FDA UDI
Model / Reference
63603NS FDA UDI
Description
FULL BREATH-NO SNORE / ACRYLIC FDA UDI

Identifiers

Primary DI / UDI-DI
D85463603NS1 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

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

Manufacturer

Manufacturer
Selane Products, Inc.

Sources (1)

  • FDA UDI 3e3aed78-82c7-4f54-9348-1b75f31016f4 33 fields · synced May 31, 2026