AccessGUDID - DEVICE: SML (D85463603LS1)

GUDID

Device Identifier (DI) Information

Brand Name: SML
Version or Model: 63603LS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SELANE PRODUCTS, INC.

Primary DI Number: D85463603LS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066642729 *Terms of Use

Device Description: FULL BREATH LOWER-THERMAL ACY W/ PTR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62239	Tongue-training sleep-disordered breathing orthosis	A removable, custom-made, intraoral device intended to improve tongue function/positioning through retraining of the tongue, by prohibiting certain tongue positions, primarily to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea). It is intended to fit onto the upper dental arcade and is made from polymer and metal materials manufactured to meet the specifications of an individual patient. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRK	Device, Anti-Snoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5c98dd0-8f84-4ddc-849c-2bce6c0f5fde
Public Version Date: October 11, 2021
Public Version Number: 4
DI Record Publish Date: August 04, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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