AccessGUDID - DEVICE: SIENTRA Nostril Retainer (00812790023455)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Nostril Retainer
Version or Model: 1171-028U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1171-028U
Company Name: Sientra, Inc.

Primary DI Number: 00812790023455
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 010209877 *Terms of Use

Device Description: Nostril Retainer w/Fixation, Solid Silicone, Smooth, 28 mm

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?
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYA	Splint, Intranasal Septal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980221	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
Width: 28 Millimeter

Device Record Status

Public Device Record Key: 6930bb61-b07a-4aac-967a-05287a1947d9
Public Version Date: October 25, 2023
Public Version Number: 7
DI Record Publish Date: October 23, 2015