AccessGUDID - DEVICE: Encore System (00862211000206)

GUDID

Device Identifier (DI) Information

Brand Name: Encore System
Version or Model: FG0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siesta Medical

Primary DI Number: 00862211000206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 940968808 *Terms of Use

Device Description: Implants and delivery tools for hyoid and tongue suspension.

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
61483	Sleep apnoea tongue implant, non-bioabsorbable	A sterile device intended to be implanted into the tongue to help increase airway patency by anterior advancement and physical stabilization of the tongue in the management of obstructive sleep apnoea (OSA). It is in the form of a non-bioabsorbable looped thread implanted in the base of the tongue, attached anteriorly to the mandible with a bone anchor. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ORY	Prelude Tongue Suspension System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133680	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 5ba93e0f-9df4-4142-a84c-cd29ee791fee
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 07, 2015

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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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