AccessGUDID - DEVICE: Pillar (10866369000009)

GUDID

Device Identifier (DI) Information

Brand Name: Pillar
Version or Model: PDS3000M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PILLAR PALATAL, LLC

Primary DI Number: 10866369000009
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2020
Device Count: 6
Labeler D-U-N-S® Number*: 079299628 *Terms of Use

Device Description: No description.

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):	Yes
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?
61437	Sleep apnoea palate implant, non-bioabsorbable	A sterile device intended to be implanted into the soft palate to help increase airway patency by physical stabilization of the soft palate in the management of snoring and obstructive sleep apnoea (OSA). The implant is made of one or more non-bioabsorbable synthetic polymers [e.g., polyethylene (PE)] and has a short rod-like shape. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LRK	Device, Anti-Snoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110623	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
Handling Environment Temperature: between -25 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a9ffb63-0cdb-4770-8ae4-be7ce121c869
Public Version Date: March 18, 2021
Public Version Number: 4
DI Record Publish Date: August 15, 2016

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: 00866369000002 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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