AccessGUDID - DEVICE: SIENTRA Nasal Implant (00812790023196)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Nasal Implant
Version or Model: 71-060U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71-060U
Company Name: Sientra, Inc.

Primary DI Number: 00812790023196
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: Nasal Implant, 'L', Solid Silicone White, 25/50 Sh A, Smooth, 60 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
31038	Nasal cartilage support implant, non-bioabsorbable	A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZE	Prosthesis, Nose, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981833	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
Length: 60 Millimeter

Device Record Status

Public Device Record Key: 50f6bdad-888e-4c27-b9af-3f7906179ebc
Public Version Date: March 05, 2024
Public Version Number: 7
DI Record Publish Date: October 23, 2015